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HomeSearchRxCUI 198334: Brands

NDC properties for "SMX 400 MG / TMP 80 MG Oral Tablet" (RxCUI 198334)

About this data

The tables show NDC propoerties for SMX 400 MG / TMP 80 MG Oral Tablet with the RxCUI 198334

This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product

Details for SMX 400 MG / TMP 80 MG Oral Tablet (RxCUI 198334)

ANDAANDA071017
ANDAANDA076817
ANDAANDA076899
ANDAANDA078060
ANDAANDA090624
MMSL_CODEBD3240
MMSL_CODECD3240
RxCUI198334
SNOMEDCT324357002
SPL_SET_ID1b5de94f-973a-4b5a-91d7-45e05be78650
SPL_SET_ID284b5dac-2b8d-46bf-95fe-80ce03fa178a
SPL_SET_ID29df8839-3dfa-0b2b-c5a3-906db6997b3b
SPL_SET_ID2d510d20-dd62-4b7a-b925-a3b71256a049
SPL_SET_ID3233c54d-484d-4550-b172-db8af47d1b7f
SPL_SET_ID32e2b197-e171-444d-86ca-198d4c84d7a5
SPL_SET_ID3edca473-8fdc-462a-b378-6c3279503a70
SPL_SET_ID407fe0e4-f1e9-4876-e054-00144ff88e88
SPL_SET_ID4833319a-a7b3-4bf4-bec4-6531b43182d4
SPL_SET_ID5c51042b-892c-f688-e053-2a91aa0a44d9
SPL_SET_ID7f25bff3-0e86-4bec-b293-54b68347867f
SPL_SET_ID9f130443-c8e7-9122-8f27-f72f07f3f29e
SPL_SET_IDbd3161fe-23d7-458a-86a4-fb958d9c94d3
SPL_SET_IDce44959b-4bfe-4ba9-9fc2-7f9d4663d542
SPL_SET_IDe1a3748d-ca73-4e56-95ad-d25189cc346e
SPL_SET_IDe4a7572f-b372-40eb-963f-919ac100b7a8
SPL_SET_IDf0e73842-6002-43c2-97fc-0cadc1bf6346
SPL_SET_IDfb9d264a-0536-4517-84f1-2ea2f57658fe
VUID4001954
VUID4008223
VUID4013974
Prescribable Synonymsulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet
RXNAV_STRsulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet
RxNorm Namesulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet
RxNorm SynonymSMX 400 MG / TMP 80 MG Oral Tablet
Related queriesInteractions (for RxCUI 198334)



NDC Properties

NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 0093-0088

NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 0093-0088

NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
Related queriesProperties for NDC 9

NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
Related queriesProperties for NDC 9 0603-5780

NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
Related queriesProperties for NDC 9 53746-271

NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
Related queriesProperties for NDC 9 53746-271

NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 57237-232

NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 60429-258

NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
Related queriesProperties for NDC 9 60687-542

NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
Related queriesProperties for NDC 9 60687-542

NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 60687-603

NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 61971-115

NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 61971-115

NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 62135-897

NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
Related queriesProperties for NDC 9 65162-271

NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 65862-419

NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 65862-419

NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
Related queriesProperties for NDC 9 68084-747

NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 69043-010

NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
Related queriesProperties for NDC 9

NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
Related queriesProperties for NDC 9 65162-271

NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 65862-419

NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 70518-3454

NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
Related queriesProperties for NDC 9

NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 0093-0088

NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
Related queriesProperties for NDC 9

NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 65862-419

NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 0093-0088

NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 0093-0088

NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
Related queriesProperties for NDC 9

NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 65862-419

NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 0093-0088

NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
Related queriesProperties for NDC 9

NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
Related queriesProperties for NDC 9 0603-5780

NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
Related queriesProperties for NDC 9

NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
Related queriesProperties for NDC 9

NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
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Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
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ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
Related queriesProperties for NDC 9

NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
Related queriesProperties for NDC 9

NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 0093-0088

NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
Related queriesProperties for NDC 9

NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
Related queriesProperties for NDC 9

NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 65862-419

NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
Related queriesProperties for NDC 9

NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 50268-728

NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
Related queriesProperties for NDC 9

NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
Related queriesProperties for NDC 9

NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 61971-115

NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 61971-115

NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 62135-897

NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
Related queriesProperties for NDC 9 65162-271

NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
Related queriesProperties for NDC 9 65162-271

NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
Related queriesProperties for NDC 9 65162-271

NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
Related queriesProperties for NDC 9 65162-271

NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 65862-419

NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 69043-010

NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 0093-0088

NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 0093-0088

NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
Related queriesProperties for NDC 9

NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
Related queriesProperties for NDC 9 0603-5780

NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
Related queriesProperties for NDC 9 33261-396

NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
Related queriesProperties for NDC 9 49999-503

NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 50268-728

NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
Related queriesProperties for NDC 9 53746-271

NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 57237-232

NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 61971-115

NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 61971-115

NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 57237-232

NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 62135-897

NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
Related queriesProperties for NDC 9 65162-271

NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
Related queriesProperties for NDC 9 65162-271

NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 00093008801

NDC 90093-0088
NDC 100093-0088-01
NDC Item00093008801
Packaging100 TABLET in 1 BOTTLE (0093-0088-01)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00093008805

NDC 90093-0088
NDC 100093-0088-05
NDC Item00093008805
Packaging500 TABLET in 1 BOTTLE (0093-0088-05)
ANDAANDA070030
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id120175
Imprint code93;088
LabelerTeva Pharmaceuticals USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2009-01-31
Marketing effective time low1990-09-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 00527144201

NDC 10UNKNOWN
NDC Item00527144201
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NDC Item 00603578021

NDC 90603-5780
NDC 100603-5780-21
NDC Item00603578021
Packaging100 TABLET in 1 BOTTLE, PLASTIC (0603-5780-21)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 00603578028

NDC 90603-5780
NDC 100603-5780-28
NDC Item00603578028
Packaging500 TABLET in 1 BOTTLE, PLASTIC (0603-5780-28)
ANDAANDA078060
COLORTEXTWHITE(to off white)
ColorC48325 __
FDA SPL set id225134
Imprint code5897;V
LabelerENDO USA, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2012-06-02
Marketing effective time low2007-01-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size12 mm
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NDC Item 33261039600

NDC 933261-396
NDC 1033261-396-00
NDC Item33261039600
Packaging100 TABLET in 1 BOTTLE (33261-396-00)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 33261039630

NDC 933261-396
NDC 1033261-396-30
NDC Item33261039630
Packaging30 TABLET in 1 BOTTLE (33261-396-30)
ANDAANDA076899
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id79225
Imprint codeIP;271
LabelerAidarex Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075801

NDC 942291-758
NDC 1042291-758-01
NDC Item42291075801
Packaging100 TABLET in 1 BOTTLE (42291-758-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 42291075850

NDC 942291-758
NDC 1042291-758-50
NDC Item42291075850
Packaging500 TABLET in 1 BOTTLE (42291-758-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id762247
Imprint codeIP;271
LabelerAvKARE
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2015-08-05
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 49999050320

NDC 949999-503
NDC 1049999-503-20
NDC Item49999050320
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NDC Item 50268072811

NDC 950268-728
NDC 1050268-728-11
NDC Item50268072811
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 50268072815

NDC 950268-728
NDC 1050268-728-15
NDC Item50268072815
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id761104
Imprint codeH;48
LabelerAvPAK
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2014-09-23
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 53489014501

NDC 953489-145
NDC 1053489-145-01
NDC Item53489014501
Packaging100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53489014505

NDC 953489-145
NDC 1053489-145-05
NDC Item53489014505
Packaging500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id800305
Imprint codeMP;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low1986-08-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 53746027101

NDC 953746-271
NDC 1053746-271-01
NDC Item53746027101
Packaging100 TABLET in 1 BOTTLE (53746-271-01)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027105

NDC 953746-271
NDC 1053746-271-05
NDC Item53746027105
Packaging500 TABLET in 1 BOTTLE (53746-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027110

NDC 953746-271
NDC 1053746-271-10
NDC Item53746027110
Packaging1000 TABLET in 1 BOTTLE (53746-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 53746027150

NDC 953746-271
NDC 1053746-271-50
NDC Item53746027150
Packaging50 TABLET in 1 BOTTLE (53746-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id810836
Imprint codeIP;271
LabelerAmneal Pharmaceuticals of New York LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48345
Size13 mm
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NDC Item 55289045720

NDC 955289-457
NDC 1055289-457-20
NDC Item55289045720
Packaging20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id626473
Imprint codeIP;271
LabelerPD-Rx Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2022-04-29
Marketing effective time low2010-02-25
Marketing statusCOMPLETED
Score2
ShapeC48345
Size13 mm
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NDC Item 57237023201

NDC 957237-232
NDC 1057237-232-01
NDC Item57237023201
Packaging100 TABLET in 1 BOTTLE (57237-232-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 57237023205

NDC 957237-232
NDC 1057237-232-05
NDC Item57237023205
Packaging500 TABLET in 1 BOTTLE (57237-232-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id808929
Imprint codeH;48
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60429025801

NDC 960429-258
NDC 1060429-258-01
NDC Item60429025801
Packaging100 TABLET in 1 BOTTLE, PLASTIC (60429-258-01)
ANDAANDA071017
COLORTEXTwhite
ColorC48325 __
FDA SPL set id572932
Imprint codeMP;81
LabelerGolden State Medical Supply, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2018-09-30
Marketing effective time low1986-08-25
Marketing statusCOMPLETED
Score2
ShapeC48348
Size11 mm
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NDC Item 60687054211

NDC 960687-542
NDC 1060687-542-11
NDC Item60687054211
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687054221

NDC 960687-542
NDC 1060687-542-21
NDC Item60687054221
Packaging30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-542-21) / 1 TABLET in 1 BLISTER PACK (60687-542-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id625009
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2023-08-31
Marketing effective time low2020-01-02
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 60687060311

NDC 960687-603
NDC 1060687-603-11
NDC Item60687060311
Packaging1 in 1 BLISTER PACK
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 60687060365

NDC 960687-603
NDC 1060687-603-65
NDC Item60687060365
Packaging50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) / 1 TABLET in 1 BLISTER PACK (60687-603-11)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id660557
Imprint codeH;48
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-01-31
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 61971011501

NDC 961971-115
NDC 1061971-115-01
NDC Item61971011501
Packaging100 TABLET in 1 BOTTLE (61971-115-01)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 61971011505

NDC 961971-115
NDC 1061971-115-05
NDC Item61971011505
Packaging500 TABLET in 1 BOTTLE (61971-115-05)
ANDAANDA076817
COLORTEXTwhite
ColorC48325 __
FDA SPL set id447833
Imprint codeVISTA115
LabelerVista Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2006-06-06
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089718

NDC 962135-897
NDC 1062135-897-18
NDC Item62135089718
Packaging180 TABLET in 1 BOTTLE (62135-897-18)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 62135089790

NDC 962135-897
NDC 1062135-897-90
NDC Item62135089790
Packaging90 TABLET in 1 BOTTLE (62135-897-90)
ANDAANDA078060
COLORTEXTwhite(white to off white)
ColorC48325 __
FDA SPL set id768757
Imprint codeCE;103
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2007-01-25
Marketing statusACTIVE
Score2
ShapeC48348
Size11 mm
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NDC Item 65162027105

NDC 965162-271
NDC 1065162-271-05
NDC Item65162027105
Packaging50 TABLET in 1 BOTTLE (65162-271-05)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027110

NDC 965162-271
NDC 1065162-271-10
NDC Item65162027110
Packaging100 TABLET in 1 BOTTLE (65162-271-10)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027111

NDC 965162-271
NDC 1065162-271-11
NDC Item65162027111
Packaging1000 TABLET in 1 BOTTLE (65162-271-11)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65162027150

NDC 965162-271
NDC 1065162-271-50
NDC Item65162027150
Packaging500 TABLET in 1 BOTTLE (65162-271-50)
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id764616
Imprint codeIP;271
LabelerAmneal Pharmaceuticals LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-25
Marketing statusACTIVE
Score2
ShapeC48348
Size13 mm
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NDC Item 65862041901

NDC 965862-419
NDC 1065862-419-01
NDC Item65862041901
Packaging100 TABLET in 1 BOTTLE (65862-419-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041905

NDC 965862-419
NDC 1065862-419-05
NDC Item65862041905
Packaging500 TABLET in 1 BOTTLE (65862-419-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041920

NDC 965862-419
NDC 1065862-419-20
NDC Item65862041920
Packaging20 TABLET in 1 BOTTLE (65862-419-20)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 65862041999

NDC 965862-419
NDC 1065862-419-99
NDC Item65862041999
Packaging1000 TABLET in 1 BOTTLE (65862-419-99)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id799337
Imprint codeH;48
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 68084074795

NDC 968084-747
NDC 1068084-747-95
NDC Item68084074795
Packaging1 in 1 BLISTER PACK
ANDAANDA076899
COLORTEXTwhite
ColorC48325 __
FDA SPL set id486635
Imprint codeIP;271
LabelerAmerican Health Packaging
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-08-31
Marketing effective time low2014-05-30
Marketing statusCOMPLETED
Score2
ShapeC48348
Size13 mm
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NDC Item 69043001001

NDC 969043-010
NDC 1069043-010-01
NDC Item69043001001
Packaging100 TABLET in 1 BOTTLE (69043-010-01)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
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NDC Item 69043001005

NDC 969043-010
NDC 1069043-010-05
NDC Item69043001005
Packaging500 TABLET in 1 BOTTLE (69043-010-05)
ANDAANDA090624
COLORTEXTWHITE(White to Off-white)
ColorC48325 __
FDA SPL set id807328
Imprint codeH;48
LabelerCronus Pharma LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2010-02-16
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 69043-010

NDC Item 70518345400

NDC 970518-3454
NDC 1070518-3454-0
NDC Item70518345400
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 70518-3454

NDC Item 70518345401

NDC 970518-3454
NDC 1070518-3454-1
NDC Item70518345401
Packaging14 TABLET in 1 BOTTLE, PLASTIC (70518-3454-1)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusACTIVE
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 70518-3454

NDC Item 70518345402

NDC 970518-3454
NDC 1070518-3454-2
NDC Item70518345402
Packaging6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
ANDAANDA090624
COLORTEXTwhite(White to Off-white)
ColorC48325 __
FDA SPL set id800133
Imprint codeH;48
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-07-18
Marketing statusactive
Score2
ShapetextBeveled Edge
ShapeC48348
Size11 mm
Related queriesProperties for NDC 9 70518-3454