RxSearch

NDC properties for "tinidazole 500 MG Oral Tablet" (RxCUI 199519)

About this data

The tables show NDC propoerties for tinidazole 500 MG Oral Tablet with the RxCUI 199519

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 tinidazole 500 MG Oral Tablet (RxCUI 199519)

ANDAANDA201172
ANDAANDA202044
ANDAANDA202489
ANDAANDA203808
MMSL_CODEBD9302
MMSL_CODECD9302
RxCUI199519
SNOMEDCT324554008
SPL_SET_ID32167dd7-5d37-457b-9b00-cd735de6b060
SPL_SET_ID45fa3ebd-52da-4987-82a1-4a64f99785a7
SPL_SET_ID4e03b4ac-c88a-4044-9d58-0cfcda3db53c
SPL_SET_ID6f3ce597-64c1-4204-a67a-8b6f6e7e8bca
SPL_SET_ID95ab57b2-5d7e-4986-abcd-65edf1728383
SPL_SET_ID9719883b-496d-42bb-e053-2995a90a1ab1
SPL_SET_IDb39bc167-f1c4-4169-8b46-e6c2eafe6bbf
SPL_SET_IDebe89ab6-24c0-4214-853f-67e2e0c7daa9
SPL_SET_IDf4235736-3050-1ee0-e053-2a95a90a421c
VUID4017102
Prescribable Synonymtinidazole 500 MG Oral Tablet
RXNAV_STRtinidazole 500 MG Oral Tablet
RxNorm Nametinidazole 500 MG Oral Tablet
Related queriesInteractions (for RxCUI 199519)



NDC Properties

NDC Item 00054034807

NDC 90054-0348
NDC 100054-0348-07
NDC Item00054034807
Packaging20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07)
ANDAANDA201172
COLORTEXTWHITE(Off White)
ColorC48325 __
FDA SPL set id611868
Imprint code54455
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-10-31
Marketing effective time low2012-04-30
Marketing statusCOMPLETED
Score2
ShapetextModified
ShapeC48345
Size16 mm
Related queriesProperties for NDC 9 0054-0348

NDC Item 00054034821

NDC 90054-0348
NDC 100054-0348-21
NDC Item00054034821
Packaging60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21)
ANDAANDA201172
COLORTEXTWHITE(Off White)
ColorC48325 __
FDA SPL set id611868
Imprint code54455
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-10-31
Marketing effective time low2012-04-30
Marketing statusCOMPLETED
Score2
ShapetextModified
ShapeC48345
Size16 mm
Related queriesProperties for NDC 9 0054-0348

NDC Item 16571021506

NDC 916571-215
NDC 1016571-215-06
NDC Item16571021506
Packaging60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06)
ANDAANDA202489
COLORTEXTPINK
ColorC48328 __
FDA SPL set id114445
Imprint codeTP;500
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-10
Marketing effective time low2013-10-09
Marketing statusCOMPLETED
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 16571-215

NDC Item 42799020801

NDC 942799-208
NDC 1042799-208-01
NDC Item42799020801
Packaging20 TABLET in 1 BOTTLE (42799-208-01)
ANDAANDA203808
COLORTEXTYELLOW
ColorC48330 __
FDA SPL set id624893
Imprint code208
LabelerEdenbridge Pharmaceuticals LLC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-12-20
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
Related queriesProperties for NDC 9 42799-208

NDC Item 42799020802

NDC 942799-208
NDC 1042799-208-02
NDC Item42799020802
Packaging60 TABLET in 1 BOTTLE (42799-208-02)
ANDAANDA203808
COLORTEXTYELLOW
ColorC48330 __
FDA SPL set id624893
Imprint code208
LabelerEdenbridge Pharmaceuticals LLC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-12-20
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
Related queriesProperties for NDC 9 42799-208

NDC Item 43386055102

NDC 943386-551
NDC 1043386-551-02
NDC Item43386055102
Packaging20 TABLET in 1 BOTTLE (43386-551-02)
ANDAANDA202044
COLORTEXTPINK
ColorC48328 __
FDA SPL set id716141
Imprint codeNL;551
LabelerLupin Pharmaceuticals,Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
Related queriesProperties for NDC 9 43386-551

NDC Item 43386055106

NDC 943386-551
NDC 1043386-551-06
NDC Item43386055106
Packaging60 TABLET in 1 BOTTLE (43386-551-06)
ANDAANDA202044
COLORTEXTPINK
ColorC48328 __
FDA SPL set id716141
Imprint codeNL;551
LabelerLupin Pharmaceuticals,Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
Related queriesProperties for NDC 9 43386-551

NDC Item 44523045020

NDC 944523-450
NDC 1044523-450-20
NDC Item44523045020
Packaging20 TABLET in 1 BOTTLE (44523-450-20)
COLORTEXTPINK
ColorC48328 __
FDA SPL set id71195
Imprint codeTM;500
LabelerBiocomp Pharma, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA AUTHORIZED GENERIC
Marketing effective time high2019-02-05
Marketing effective time low2012-06-07
Marketing statusCOMPLETED
NDA_AUTHORIZED_GENERICNDA021618
Score2
ShapeC48345
Size14 mm
Related queriesProperties for NDC 9 44523-450

NDC Item 62135083520

NDC 962135-835
NDC 1062135-835-20
NDC Item62135083520
Packaging20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20)
ANDAANDA202044
COLORTEXTwhite(white to off-white)
ColorC48325 __
FDA SPL set id798224
Imprint codeC;E;205
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusactive
Score2
ShapeC48345
Size16 mm
Related queriesProperties for NDC 9 62135-835

NDC Item 64980042712

NDC 964980-427
NDC 1064980-427-12
NDC Item64980042712
Packaging12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12)
ANDAANDA202489
COLORTEXTPINK
ColorC48328 __
FDA SPL set id717670
Imprint codeTP;500
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-10-09
Marketing statusACTIVE
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 64980-427

NDC Item 67296183608

NDC 967296-1836
NDC 1067296-1836-8
NDC Item67296183608
Packaging8 TABLET, FILM COATED in 1 BOTTLE (67296-1836-8)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id798328
Imprint codeTP;500
LabelerRedpharm Drug, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-10-09
Marketing statusACTIVE
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 67296-1836

NDC Item 70518417200

NDC 970518-4172
NDC 1070518-4172-0
NDC Item70518417200
Packaging8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-0)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id807843
Imprint codeTP;500
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-30
Marketing statusactive
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 70518-4172

NDC Item 70518417201

NDC 970518-4172
NDC 1070518-4172-1
NDC Item70518417201
Packaging10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id807843
Imprint codeTP;500
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-30
Marketing statusactive
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 70518-4172

NDC Item 00054034807

NDC 90054-0348
NDC 100054-0348-07
NDC Item00054034807
Packaging20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07)
ANDAANDA201172
COLORTEXTWHITE(Off White)
ColorC48325 __
FDA SPL set id611868
Imprint code54455
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-10-31
Marketing effective time low2012-04-30
Marketing statusCOMPLETED
Score2
ShapetextModified
ShapeC48345
Size16 mm
Related queriesProperties for NDC 9 0054-0348

NDC Item 00054034821

NDC 90054-0348
NDC 100054-0348-21
NDC Item00054034821
Packaging60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21)
ANDAANDA201172
COLORTEXTWHITE(Off White)
ColorC48325 __
FDA SPL set id611868
Imprint code54455
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-10-31
Marketing effective time low2012-04-30
Marketing statusCOMPLETED
Score2
ShapetextModified
ShapeC48345
Size16 mm
Related queriesProperties for NDC 9 0054-0348

NDC Item 16571021506

NDC 916571-215
NDC 1016571-215-06
NDC Item16571021506
Packaging60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06)
ANDAANDA202489
COLORTEXTPINK
ColorC48328 __
FDA SPL set id114445
Imprint codeTP;500
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-10
Marketing effective time low2013-10-09
Marketing statusCOMPLETED
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 16571-215

NDC Item 42799020801

NDC 942799-208
NDC 1042799-208-01
NDC Item42799020801
Packaging20 TABLET in 1 BOTTLE (42799-208-01)
ANDAANDA203808
COLORTEXTYELLOW
ColorC48330 __
FDA SPL set id624893
Imprint code208
LabelerEdenbridge Pharmaceuticals LLC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-12-20
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
Related queriesProperties for NDC 9 42799-208

NDC Item 42799020802

NDC 942799-208
NDC 1042799-208-02
NDC Item42799020802
Packaging60 TABLET in 1 BOTTLE (42799-208-02)
ANDAANDA203808
COLORTEXTYELLOW
ColorC48330 __
FDA SPL set id624893
Imprint code208
LabelerEdenbridge Pharmaceuticals LLC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-12-20
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
Related queriesProperties for NDC 9 42799-208

NDC Item 43386055102

NDC 943386-551
NDC 1043386-551-02
NDC Item43386055102
Packaging20 TABLET in 1 BOTTLE (43386-551-02)
ANDAANDA202044
COLORTEXTPINK
ColorC48328 __
FDA SPL set id716141
Imprint codeNL;551
LabelerLupin Pharmaceuticals,Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
Related queriesProperties for NDC 9 43386-551

NDC Item 43386055106

NDC 943386-551
NDC 1043386-551-06
NDC Item43386055106
Packaging60 TABLET in 1 BOTTLE (43386-551-06)
ANDAANDA202044
COLORTEXTPINK
ColorC48328 __
FDA SPL set id716141
Imprint codeNL;551
LabelerLupin Pharmaceuticals,Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
Related queriesProperties for NDC 9 43386-551

NDC Item 44523045020

NDC 944523-450
NDC 1044523-450-20
NDC Item44523045020
Packaging20 TABLET in 1 BOTTLE (44523-450-20)
COLORTEXTPINK
ColorC48328 __
FDA SPL set id71195
Imprint codeTM;500
LabelerBiocomp Pharma, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA AUTHORIZED GENERIC
Marketing effective time high2019-02-05
Marketing effective time low2012-06-07
Marketing statusCOMPLETED
NDA_AUTHORIZED_GENERICNDA021618
Score2
ShapeC48345
Size14 mm
Related queriesProperties for NDC 9 44523-450

NDC Item 62135083520

NDC 962135-835
NDC 1062135-835-20
NDC Item62135083520
Packaging20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20)
ANDAANDA202044
COLORTEXTwhite(white to off-white)
ColorC48325 __
FDA SPL set id798224
Imprint codeC;E;205
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusactive
Score2
ShapeC48345
Size16 mm
Related queriesProperties for NDC 9 62135-835

NDC Item 64980042712

NDC 964980-427
NDC 1064980-427-12
NDC Item64980042712
Packaging12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12)
ANDAANDA202489
COLORTEXTPINK
ColorC48328 __
FDA SPL set id717670
Imprint codeTP;500
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-10-09
Marketing statusACTIVE
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 64980-427

NDC Item 67296183608

NDC 967296-1836
NDC 1067296-1836-8
NDC Item67296183608
Packaging8 TABLET, FILM COATED in 1 BOTTLE (67296-1836-8)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id798328
Imprint codeTP;500
LabelerRedpharm Drug, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-10-09
Marketing statusACTIVE
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 67296-1836

NDC Item 70518417200

NDC 970518-4172
NDC 1070518-4172-0
NDC Item70518417200
Packaging8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-0)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id807843
Imprint codeTP;500
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-30
Marketing statusactive
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 70518-4172

NDC Item 70518417201

NDC 970518-4172
NDC 1070518-4172-1
NDC Item70518417201
Packaging10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id807843
Imprint codeTP;500
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-30
Marketing statusactive
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 70518-4172

NDC Item 00054034807

NDC 90054-0348
NDC 100054-0348-07
NDC Item00054034807
Packaging20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07)
ANDAANDA201172
COLORTEXTWHITE(Off White)
ColorC48325 __
FDA SPL set id611868
Imprint code54455
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-10-31
Marketing effective time low2012-04-30
Marketing statusCOMPLETED
Score2
ShapetextModified
ShapeC48345
Size16 mm
Related queriesProperties for NDC 9 0054-0348

NDC Item 00054034821

NDC 90054-0348
NDC 100054-0348-21
NDC Item00054034821
Packaging60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21)
ANDAANDA201172
COLORTEXTWHITE(Off White)
ColorC48325 __
FDA SPL set id611868
Imprint code54455
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-10-31
Marketing effective time low2012-04-30
Marketing statusCOMPLETED
Score2
ShapetextModified
ShapeC48345
Size16 mm
Related queriesProperties for NDC 9 0054-0348

NDC Item 16571021506

NDC 916571-215
NDC 1016571-215-06
NDC Item16571021506
Packaging60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06)
ANDAANDA202489
COLORTEXTPINK
ColorC48328 __
FDA SPL set id114445
Imprint codeTP;500
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-10
Marketing effective time low2013-10-09
Marketing statusCOMPLETED
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 16571-215

NDC Item 42799020801

NDC 942799-208
NDC 1042799-208-01
NDC Item42799020801
Packaging20 TABLET in 1 BOTTLE (42799-208-01)
ANDAANDA203808
COLORTEXTYELLOW
ColorC48330 __
FDA SPL set id624893
Imprint code208
LabelerEdenbridge Pharmaceuticals LLC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-12-20
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
Related queriesProperties for NDC 9 42799-208

NDC Item 42799020802

NDC 942799-208
NDC 1042799-208-02
NDC Item42799020802
Packaging60 TABLET in 1 BOTTLE (42799-208-02)
ANDAANDA203808
COLORTEXTYELLOW
ColorC48330 __
FDA SPL set id624893
Imprint code208
LabelerEdenbridge Pharmaceuticals LLC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-12-20
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
Related queriesProperties for NDC 9 42799-208

NDC Item 43386055102

NDC 943386-551
NDC 1043386-551-02
NDC Item43386055102
Packaging20 TABLET in 1 BOTTLE (43386-551-02)
ANDAANDA202044
COLORTEXTPINK
ColorC48328 __
FDA SPL set id716141
Imprint codeNL;551
LabelerLupin Pharmaceuticals,Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
Related queriesProperties for NDC 9 43386-551

NDC Item 43386055106

NDC 943386-551
NDC 1043386-551-06
NDC Item43386055106
Packaging60 TABLET in 1 BOTTLE (43386-551-06)
ANDAANDA202044
COLORTEXTPINK
ColorC48328 __
FDA SPL set id716141
Imprint codeNL;551
LabelerLupin Pharmaceuticals,Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
Related queriesProperties for NDC 9 43386-551

NDC Item 44523045020

NDC 944523-450
NDC 1044523-450-20
NDC Item44523045020
Packaging20 TABLET in 1 BOTTLE (44523-450-20)
COLORTEXTPINK
ColorC48328 __
FDA SPL set id71195
Imprint codeTM;500
LabelerBiocomp Pharma, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA AUTHORIZED GENERIC
Marketing effective time high2019-02-05
Marketing effective time low2012-06-07
Marketing statusCOMPLETED
NDA_AUTHORIZED_GENERICNDA021618
Score2
ShapeC48345
Size14 mm
Related queriesProperties for NDC 9 44523-450

NDC Item 62135083520

NDC 962135-835
NDC 1062135-835-20
NDC Item62135083520
Packaging20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20)
ANDAANDA202044
COLORTEXTwhite(white to off-white)
ColorC48325 __
FDA SPL set id798224
Imprint codeC;E;205
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusactive
Score2
ShapeC48345
Size16 mm
Related queriesProperties for NDC 9 62135-835

NDC Item 64980042712

NDC 964980-427
NDC 1064980-427-12
NDC Item64980042712
Packaging12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12)
ANDAANDA202489
COLORTEXTPINK
ColorC48328 __
FDA SPL set id717670
Imprint codeTP;500
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-10-09
Marketing statusACTIVE
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 64980-427

NDC Item 67296183608

NDC 967296-1836
NDC 1067296-1836-8
NDC Item67296183608
Packaging8 TABLET, FILM COATED in 1 BOTTLE (67296-1836-8)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id798328
Imprint codeTP;500
LabelerRedpharm Drug, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-10-09
Marketing statusACTIVE
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 67296-1836

NDC Item 70518417200

NDC 970518-4172
NDC 1070518-4172-0
NDC Item70518417200
Packaging8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-0)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id807843
Imprint codeTP;500
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-30
Marketing statusactive
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 70518-4172

NDC Item 70518417201

NDC 970518-4172
NDC 1070518-4172-1
NDC Item70518417201
Packaging10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id807843
Imprint codeTP;500
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-30
Marketing statusactive
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 70518-4172

NDC Item 00054034807

NDC 90054-0348
NDC 100054-0348-07
NDC Item00054034807
Packaging20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07)
ANDAANDA201172
COLORTEXTWHITE(Off White)
ColorC48325 __
FDA SPL set id611868
Imprint code54455
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-10-31
Marketing effective time low2012-04-30
Marketing statusCOMPLETED
Score2
ShapetextModified
ShapeC48345
Size16 mm
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NDC Item 00054034821

NDC 90054-0348
NDC 100054-0348-21
NDC Item00054034821
Packaging60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21)
ANDAANDA201172
COLORTEXTWHITE(Off White)
ColorC48325 __
FDA SPL set id611868
Imprint code54455
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-10-31
Marketing effective time low2012-04-30
Marketing statusCOMPLETED
Score2
ShapetextModified
ShapeC48345
Size16 mm
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NDC Item 16571021506

NDC 916571-215
NDC 1016571-215-06
NDC Item16571021506
Packaging60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06)
ANDAANDA202489
COLORTEXTPINK
ColorC48328 __
FDA SPL set id114445
Imprint codeTP;500
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-10
Marketing effective time low2013-10-09
Marketing statusCOMPLETED
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 42799020801

NDC 942799-208
NDC 1042799-208-01
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Packaging20 TABLET in 1 BOTTLE (42799-208-01)
ANDAANDA203808
COLORTEXTYELLOW
ColorC48330 __
FDA SPL set id624893
Imprint code208
LabelerEdenbridge Pharmaceuticals LLC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-12-20
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC 942799-208
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Packaging60 TABLET in 1 BOTTLE (42799-208-02)
ANDAANDA203808
COLORTEXTYELLOW
ColorC48330 __
FDA SPL set id624893
Imprint code208
LabelerEdenbridge Pharmaceuticals LLC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-12-20
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 43386055102

NDC 943386-551
NDC 1043386-551-02
NDC Item43386055102
Packaging20 TABLET in 1 BOTTLE (43386-551-02)
ANDAANDA202044
COLORTEXTPINK
ColorC48328 __
FDA SPL set id716141
Imprint codeNL;551
LabelerLupin Pharmaceuticals,Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 43386055106

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NDC 1043386-551-06
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Packaging60 TABLET in 1 BOTTLE (43386-551-06)
ANDAANDA202044
COLORTEXTPINK
ColorC48328 __
FDA SPL set id716141
Imprint codeNL;551
LabelerLupin Pharmaceuticals,Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 44523045020

NDC 944523-450
NDC 1044523-450-20
NDC Item44523045020
Packaging20 TABLET in 1 BOTTLE (44523-450-20)
COLORTEXTPINK
ColorC48328 __
FDA SPL set id71195
Imprint codeTM;500
LabelerBiocomp Pharma, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA AUTHORIZED GENERIC
Marketing effective time high2019-02-05
Marketing effective time low2012-06-07
Marketing statusCOMPLETED
NDA_AUTHORIZED_GENERICNDA021618
Score2
ShapeC48345
Size14 mm
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NDC Item 62135083520

NDC 962135-835
NDC 1062135-835-20
NDC Item62135083520
Packaging20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20)
ANDAANDA202044
COLORTEXTwhite(white to off-white)
ColorC48325 __
FDA SPL set id798224
Imprint codeC;E;205
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusactive
Score2
ShapeC48345
Size16 mm
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NDC Item 64980042712

NDC 964980-427
NDC 1064980-427-12
NDC Item64980042712
Packaging12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12)
ANDAANDA202489
COLORTEXTPINK
ColorC48328 __
FDA SPL set id717670
Imprint codeTP;500
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-10-09
Marketing statusACTIVE
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 67296183608

NDC 967296-1836
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ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id798328
Imprint codeTP;500
LabelerRedpharm Drug, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-10-09
Marketing statusACTIVE
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 70518417200

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ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id807843
Imprint codeTP;500
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-30
Marketing statusactive
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 70518417201

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NDC 1070518-4172-1
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Packaging10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id807843
Imprint codeTP;500
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-30
Marketing statusactive
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 00054034807

NDC 90054-0348
NDC 100054-0348-07
NDC Item00054034807
Packaging20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07)
ANDAANDA201172
COLORTEXTWHITE(Off White)
ColorC48325 __
FDA SPL set id611868
Imprint code54455
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-10-31
Marketing effective time low2012-04-30
Marketing statusCOMPLETED
Score2
ShapetextModified
ShapeC48345
Size16 mm
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NDC Item 00054034821

NDC 90054-0348
NDC 100054-0348-21
NDC Item00054034821
Packaging60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21)
ANDAANDA201172
COLORTEXTWHITE(Off White)
ColorC48325 __
FDA SPL set id611868
Imprint code54455
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-10-31
Marketing effective time low2012-04-30
Marketing statusCOMPLETED
Score2
ShapetextModified
ShapeC48345
Size16 mm
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NDC Item 16571021506

NDC 916571-215
NDC 1016571-215-06
NDC Item16571021506
Packaging60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06)
ANDAANDA202489
COLORTEXTPINK
ColorC48328 __
FDA SPL set id114445
Imprint codeTP;500
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-10
Marketing effective time low2013-10-09
Marketing statusCOMPLETED
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 42799020801

NDC 942799-208
NDC 1042799-208-01
NDC Item42799020801
Packaging20 TABLET in 1 BOTTLE (42799-208-01)
ANDAANDA203808
COLORTEXTYELLOW
ColorC48330 __
FDA SPL set id624893
Imprint code208
LabelerEdenbridge Pharmaceuticals LLC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-12-20
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 42799020802

NDC 942799-208
NDC 1042799-208-02
NDC Item42799020802
Packaging60 TABLET in 1 BOTTLE (42799-208-02)
ANDAANDA203808
COLORTEXTYELLOW
ColorC48330 __
FDA SPL set id624893
Imprint code208
LabelerEdenbridge Pharmaceuticals LLC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-12-20
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 43386055102

NDC 943386-551
NDC 1043386-551-02
NDC Item43386055102
Packaging20 TABLET in 1 BOTTLE (43386-551-02)
ANDAANDA202044
COLORTEXTPINK
ColorC48328 __
FDA SPL set id716141
Imprint codeNL;551
LabelerLupin Pharmaceuticals,Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 43386055106

NDC 943386-551
NDC 1043386-551-06
NDC Item43386055106
Packaging60 TABLET in 1 BOTTLE (43386-551-06)
ANDAANDA202044
COLORTEXTPINK
ColorC48328 __
FDA SPL set id716141
Imprint codeNL;551
LabelerLupin Pharmaceuticals,Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 44523045020

NDC 944523-450
NDC 1044523-450-20
NDC Item44523045020
Packaging20 TABLET in 1 BOTTLE (44523-450-20)
COLORTEXTPINK
ColorC48328 __
FDA SPL set id71195
Imprint codeTM;500
LabelerBiocomp Pharma, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA AUTHORIZED GENERIC
Marketing effective time high2019-02-05
Marketing effective time low2012-06-07
Marketing statusCOMPLETED
NDA_AUTHORIZED_GENERICNDA021618
Score2
ShapeC48345
Size14 mm
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NDC Item 62135083520

NDC 962135-835
NDC 1062135-835-20
NDC Item62135083520
Packaging20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20)
ANDAANDA202044
COLORTEXTwhite(white to off-white)
ColorC48325 __
FDA SPL set id798224
Imprint codeC;E;205
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusactive
Score2
ShapeC48345
Size16 mm
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NDC Item 64980042712

NDC 964980-427
NDC 1064980-427-12
NDC Item64980042712
Packaging12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12)
ANDAANDA202489
COLORTEXTPINK
ColorC48328 __
FDA SPL set id717670
Imprint codeTP;500
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-10-09
Marketing statusACTIVE
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 67296183608

NDC 967296-1836
NDC 1067296-1836-8
NDC Item67296183608
Packaging8 TABLET, FILM COATED in 1 BOTTLE (67296-1836-8)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id798328
Imprint codeTP;500
LabelerRedpharm Drug, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-10-09
Marketing statusACTIVE
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 70518417200

NDC 970518-4172
NDC 1070518-4172-0
NDC Item70518417200
Packaging8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-0)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id807843
Imprint codeTP;500
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-30
Marketing statusactive
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 70518417201

NDC 970518-4172
NDC 1070518-4172-1
NDC Item70518417201
Packaging10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id807843
Imprint codeTP;500
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-30
Marketing statusactive
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 00054034807

NDC 90054-0348
NDC 100054-0348-07
NDC Item00054034807
Packaging20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07)
ANDAANDA201172
COLORTEXTWHITE(Off White)
ColorC48325 __
FDA SPL set id611868
Imprint code54455
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-10-31
Marketing effective time low2012-04-30
Marketing statusCOMPLETED
Score2
ShapetextModified
ShapeC48345
Size16 mm
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NDC Item 00054034821

NDC 90054-0348
NDC 100054-0348-21
NDC Item00054034821
Packaging60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21)
ANDAANDA201172
COLORTEXTWHITE(Off White)
ColorC48325 __
FDA SPL set id611868
Imprint code54455
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-10-31
Marketing effective time low2012-04-30
Marketing statusCOMPLETED
Score2
ShapetextModified
ShapeC48345
Size16 mm
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NDC Item 16571021506

NDC 916571-215
NDC 1016571-215-06
NDC Item16571021506
Packaging60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06)
ANDAANDA202489
COLORTEXTPINK
ColorC48328 __
FDA SPL set id114445
Imprint codeTP;500
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-10
Marketing effective time low2013-10-09
Marketing statusCOMPLETED
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 42799020801

NDC 942799-208
NDC 1042799-208-01
NDC Item42799020801
Packaging20 TABLET in 1 BOTTLE (42799-208-01)
ANDAANDA203808
COLORTEXTYELLOW
ColorC48330 __
FDA SPL set id624893
Imprint code208
LabelerEdenbridge Pharmaceuticals LLC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-12-20
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 42799020802

NDC 942799-208
NDC 1042799-208-02
NDC Item42799020802
Packaging60 TABLET in 1 BOTTLE (42799-208-02)
ANDAANDA203808
COLORTEXTYELLOW
ColorC48330 __
FDA SPL set id624893
Imprint code208
LabelerEdenbridge Pharmaceuticals LLC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-12-20
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 43386055102

NDC 943386-551
NDC 1043386-551-02
NDC Item43386055102
Packaging20 TABLET in 1 BOTTLE (43386-551-02)
ANDAANDA202044
COLORTEXTPINK
ColorC48328 __
FDA SPL set id716141
Imprint codeNL;551
LabelerLupin Pharmaceuticals,Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 43386055106

NDC 943386-551
NDC 1043386-551-06
NDC Item43386055106
Packaging60 TABLET in 1 BOTTLE (43386-551-06)
ANDAANDA202044
COLORTEXTPINK
ColorC48328 __
FDA SPL set id716141
Imprint codeNL;551
LabelerLupin Pharmaceuticals,Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 44523045020

NDC 944523-450
NDC 1044523-450-20
NDC Item44523045020
Packaging20 TABLET in 1 BOTTLE (44523-450-20)
COLORTEXTPINK
ColorC48328 __
FDA SPL set id71195
Imprint codeTM;500
LabelerBiocomp Pharma, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA AUTHORIZED GENERIC
Marketing effective time high2019-02-05
Marketing effective time low2012-06-07
Marketing statusCOMPLETED
NDA_AUTHORIZED_GENERICNDA021618
Score2
ShapeC48345
Size14 mm
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NDC Item 62135083520

NDC 962135-835
NDC 1062135-835-20
NDC Item62135083520
Packaging20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20)
ANDAANDA202044
COLORTEXTwhite(white to off-white)
ColorC48325 __
FDA SPL set id798224
Imprint codeC;E;205
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusactive
Score2
ShapeC48345
Size16 mm
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NDC Item 64980042712

NDC 964980-427
NDC 1064980-427-12
NDC Item64980042712
Packaging12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12)
ANDAANDA202489
COLORTEXTPINK
ColorC48328 __
FDA SPL set id717670
Imprint codeTP;500
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-10-09
Marketing statusACTIVE
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 67296183608

NDC 967296-1836
NDC 1067296-1836-8
NDC Item67296183608
Packaging8 TABLET, FILM COATED in 1 BOTTLE (67296-1836-8)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id798328
Imprint codeTP;500
LabelerRedpharm Drug, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-10-09
Marketing statusACTIVE
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 70518417200

NDC 970518-4172
NDC 1070518-4172-0
NDC Item70518417200
Packaging8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-0)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id807843
Imprint codeTP;500
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-30
Marketing statusactive
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 70518417201

NDC 970518-4172
NDC 1070518-4172-1
NDC Item70518417201
Packaging10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id807843
Imprint codeTP;500
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-30
Marketing statusactive
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 00054034807

NDC 90054-0348
NDC 100054-0348-07
NDC Item00054034807
Packaging20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07)
ANDAANDA201172
COLORTEXTWHITE(Off White)
ColorC48325 __
FDA SPL set id611868
Imprint code54455
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-10-31
Marketing effective time low2012-04-30
Marketing statusCOMPLETED
Score2
ShapetextModified
ShapeC48345
Size16 mm
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NDC Item 00054034821

NDC 90054-0348
NDC 100054-0348-21
NDC Item00054034821
Packaging60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21)
ANDAANDA201172
COLORTEXTWHITE(Off White)
ColorC48325 __
FDA SPL set id611868
Imprint code54455
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-10-31
Marketing effective time low2012-04-30
Marketing statusCOMPLETED
Score2
ShapetextModified
ShapeC48345
Size16 mm
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NDC Item 16571021506

NDC 916571-215
NDC 1016571-215-06
NDC Item16571021506
Packaging60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06)
ANDAANDA202489
COLORTEXTPINK
ColorC48328 __
FDA SPL set id114445
Imprint codeTP;500
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-10
Marketing effective time low2013-10-09
Marketing statusCOMPLETED
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 42799020801

NDC 942799-208
NDC 1042799-208-01
NDC Item42799020801
Packaging20 TABLET in 1 BOTTLE (42799-208-01)
ANDAANDA203808
COLORTEXTYELLOW
ColorC48330 __
FDA SPL set id624893
Imprint code208
LabelerEdenbridge Pharmaceuticals LLC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-12-20
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 42799020802

NDC 942799-208
NDC 1042799-208-02
NDC Item42799020802
Packaging60 TABLET in 1 BOTTLE (42799-208-02)
ANDAANDA203808
COLORTEXTYELLOW
ColorC48330 __
FDA SPL set id624893
Imprint code208
LabelerEdenbridge Pharmaceuticals LLC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-12-20
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 43386055102

NDC 943386-551
NDC 1043386-551-02
NDC Item43386055102
Packaging20 TABLET in 1 BOTTLE (43386-551-02)
ANDAANDA202044
COLORTEXTPINK
ColorC48328 __
FDA SPL set id716141
Imprint codeNL;551
LabelerLupin Pharmaceuticals,Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 43386055106

NDC 943386-551
NDC 1043386-551-06
NDC Item43386055106
Packaging60 TABLET in 1 BOTTLE (43386-551-06)
ANDAANDA202044
COLORTEXTPINK
ColorC48328 __
FDA SPL set id716141
Imprint codeNL;551
LabelerLupin Pharmaceuticals,Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 44523045020

NDC 944523-450
NDC 1044523-450-20
NDC Item44523045020
Packaging20 TABLET in 1 BOTTLE (44523-450-20)
COLORTEXTPINK
ColorC48328 __
FDA SPL set id71195
Imprint codeTM;500
LabelerBiocomp Pharma, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA AUTHORIZED GENERIC
Marketing effective time high2019-02-05
Marketing effective time low2012-06-07
Marketing statusCOMPLETED
NDA_AUTHORIZED_GENERICNDA021618
Score2
ShapeC48345
Size14 mm
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NDC Item 62135083520

NDC 962135-835
NDC 1062135-835-20
NDC Item62135083520
Packaging20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20)
ANDAANDA202044
COLORTEXTwhite(white to off-white)
ColorC48325 __
FDA SPL set id798224
Imprint codeC;E;205
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusactive
Score2
ShapeC48345
Size16 mm
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NDC Item 64980042712

NDC 964980-427
NDC 1064980-427-12
NDC Item64980042712
Packaging12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12)
ANDAANDA202489
COLORTEXTPINK
ColorC48328 __
FDA SPL set id717670
Imprint codeTP;500
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-10-09
Marketing statusACTIVE
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 67296183608

NDC 967296-1836
NDC 1067296-1836-8
NDC Item67296183608
Packaging8 TABLET, FILM COATED in 1 BOTTLE (67296-1836-8)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id798328
Imprint codeTP;500
LabelerRedpharm Drug, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-10-09
Marketing statusACTIVE
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 70518417200

NDC 970518-4172
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NDC Item70518417200
Packaging8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-0)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id807843
Imprint codeTP;500
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-30
Marketing statusactive
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC 1070518-4172-1
NDC Item70518417201
Packaging10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id807843
Imprint codeTP;500
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-30
Marketing statusactive
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 00054034807

NDC 90054-0348
NDC 100054-0348-07
NDC Item00054034807
Packaging20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07)
ANDAANDA201172
COLORTEXTWHITE(Off White)
ColorC48325 __
FDA SPL set id611868
Imprint code54455
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-10-31
Marketing effective time low2012-04-30
Marketing statusCOMPLETED
Score2
ShapetextModified
ShapeC48345
Size16 mm
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NDC Item 00054034821

NDC 90054-0348
NDC 100054-0348-21
NDC Item00054034821
Packaging60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21)
ANDAANDA201172
COLORTEXTWHITE(Off White)
ColorC48325 __
FDA SPL set id611868
Imprint code54455
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-10-31
Marketing effective time low2012-04-30
Marketing statusCOMPLETED
Score2
ShapetextModified
ShapeC48345
Size16 mm
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NDC Item 16571021506

NDC 916571-215
NDC 1016571-215-06
NDC Item16571021506
Packaging60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06)
ANDAANDA202489
COLORTEXTPINK
ColorC48328 __
FDA SPL set id114445
Imprint codeTP;500
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-10
Marketing effective time low2013-10-09
Marketing statusCOMPLETED
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 42799020801

NDC 942799-208
NDC 1042799-208-01
NDC Item42799020801
Packaging20 TABLET in 1 BOTTLE (42799-208-01)
ANDAANDA203808
COLORTEXTYELLOW
ColorC48330 __
FDA SPL set id624893
Imprint code208
LabelerEdenbridge Pharmaceuticals LLC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-12-20
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 42799020802

NDC 942799-208
NDC 1042799-208-02
NDC Item42799020802
Packaging60 TABLET in 1 BOTTLE (42799-208-02)
ANDAANDA203808
COLORTEXTYELLOW
ColorC48330 __
FDA SPL set id624893
Imprint code208
LabelerEdenbridge Pharmaceuticals LLC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-12-20
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 43386055102

NDC 943386-551
NDC 1043386-551-02
NDC Item43386055102
Packaging20 TABLET in 1 BOTTLE (43386-551-02)
ANDAANDA202044
COLORTEXTPINK
ColorC48328 __
FDA SPL set id716141
Imprint codeNL;551
LabelerLupin Pharmaceuticals,Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 43386055106

NDC 943386-551
NDC 1043386-551-06
NDC Item43386055106
Packaging60 TABLET in 1 BOTTLE (43386-551-06)
ANDAANDA202044
COLORTEXTPINK
ColorC48328 __
FDA SPL set id716141
Imprint codeNL;551
LabelerLupin Pharmaceuticals,Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 44523045020

NDC 944523-450
NDC 1044523-450-20
NDC Item44523045020
Packaging20 TABLET in 1 BOTTLE (44523-450-20)
COLORTEXTPINK
ColorC48328 __
FDA SPL set id71195
Imprint codeTM;500
LabelerBiocomp Pharma, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA AUTHORIZED GENERIC
Marketing effective time high2019-02-05
Marketing effective time low2012-06-07
Marketing statusCOMPLETED
NDA_AUTHORIZED_GENERICNDA021618
Score2
ShapeC48345
Size14 mm
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NDC Item 62135083520

NDC 962135-835
NDC 1062135-835-20
NDC Item62135083520
Packaging20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20)
ANDAANDA202044
COLORTEXTwhite(white to off-white)
ColorC48325 __
FDA SPL set id798224
Imprint codeC;E;205
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusactive
Score2
ShapeC48345
Size16 mm
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NDC Item 64980042712

NDC 964980-427
NDC 1064980-427-12
NDC Item64980042712
Packaging12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12)
ANDAANDA202489
COLORTEXTPINK
ColorC48328 __
FDA SPL set id717670
Imprint codeTP;500
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-10-09
Marketing statusACTIVE
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 67296183608

NDC 967296-1836
NDC 1067296-1836-8
NDC Item67296183608
Packaging8 TABLET, FILM COATED in 1 BOTTLE (67296-1836-8)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id798328
Imprint codeTP;500
LabelerRedpharm Drug, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-10-09
Marketing statusACTIVE
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 70518417200

NDC 970518-4172
NDC 1070518-4172-0
NDC Item70518417200
Packaging8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-0)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id807843
Imprint codeTP;500
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-30
Marketing statusactive
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 70518417201

NDC 970518-4172
NDC 1070518-4172-1
NDC Item70518417201
Packaging10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id807843
Imprint codeTP;500
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-30
Marketing statusactive
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 00054034807

NDC 90054-0348
NDC 100054-0348-07
NDC Item00054034807
Packaging20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07)
ANDAANDA201172
COLORTEXTWHITE(Off White)
ColorC48325 __
FDA SPL set id611868
Imprint code54455
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-10-31
Marketing effective time low2012-04-30
Marketing statusCOMPLETED
Score2
ShapetextModified
ShapeC48345
Size16 mm
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NDC Item 00054034821

NDC 90054-0348
NDC 100054-0348-21
NDC Item00054034821
Packaging60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21)
ANDAANDA201172
COLORTEXTWHITE(Off White)
ColorC48325 __
FDA SPL set id611868
Imprint code54455
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-10-31
Marketing effective time low2012-04-30
Marketing statusCOMPLETED
Score2
ShapetextModified
ShapeC48345
Size16 mm
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NDC Item 16571021506

NDC 916571-215
NDC 1016571-215-06
NDC Item16571021506
Packaging60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06)
ANDAANDA202489
COLORTEXTPINK
ColorC48328 __
FDA SPL set id114445
Imprint codeTP;500
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-10
Marketing effective time low2013-10-09
Marketing statusCOMPLETED
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 42799020801

NDC 942799-208
NDC 1042799-208-01
NDC Item42799020801
Packaging20 TABLET in 1 BOTTLE (42799-208-01)
ANDAANDA203808
COLORTEXTYELLOW
ColorC48330 __
FDA SPL set id624893
Imprint code208
LabelerEdenbridge Pharmaceuticals LLC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-12-20
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 42799020802

NDC 942799-208
NDC 1042799-208-02
NDC Item42799020802
Packaging60 TABLET in 1 BOTTLE (42799-208-02)
ANDAANDA203808
COLORTEXTYELLOW
ColorC48330 __
FDA SPL set id624893
Imprint code208
LabelerEdenbridge Pharmaceuticals LLC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-12-20
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 43386055102

NDC 943386-551
NDC 1043386-551-02
NDC Item43386055102
Packaging20 TABLET in 1 BOTTLE (43386-551-02)
ANDAANDA202044
COLORTEXTPINK
ColorC48328 __
FDA SPL set id716141
Imprint codeNL;551
LabelerLupin Pharmaceuticals,Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 43386055106

NDC 943386-551
NDC 1043386-551-06
NDC Item43386055106
Packaging60 TABLET in 1 BOTTLE (43386-551-06)
ANDAANDA202044
COLORTEXTPINK
ColorC48328 __
FDA SPL set id716141
Imprint codeNL;551
LabelerLupin Pharmaceuticals,Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 44523045020

NDC 944523-450
NDC 1044523-450-20
NDC Item44523045020
Packaging20 TABLET in 1 BOTTLE (44523-450-20)
COLORTEXTPINK
ColorC48328 __
FDA SPL set id71195
Imprint codeTM;500
LabelerBiocomp Pharma, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA AUTHORIZED GENERIC
Marketing effective time high2019-02-05
Marketing effective time low2012-06-07
Marketing statusCOMPLETED
NDA_AUTHORIZED_GENERICNDA021618
Score2
ShapeC48345
Size14 mm
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NDC Item 62135083520

NDC 962135-835
NDC 1062135-835-20
NDC Item62135083520
Packaging20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20)
ANDAANDA202044
COLORTEXTwhite(white to off-white)
ColorC48325 __
FDA SPL set id798224
Imprint codeC;E;205
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusactive
Score2
ShapeC48345
Size16 mm
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NDC Item 64980042712

NDC 964980-427
NDC 1064980-427-12
NDC Item64980042712
Packaging12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12)
ANDAANDA202489
COLORTEXTPINK
ColorC48328 __
FDA SPL set id717670
Imprint codeTP;500
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-10-09
Marketing statusACTIVE
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 67296183608

NDC 967296-1836
NDC 1067296-1836-8
NDC Item67296183608
Packaging8 TABLET, FILM COATED in 1 BOTTLE (67296-1836-8)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id798328
Imprint codeTP;500
LabelerRedpharm Drug, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-10-09
Marketing statusACTIVE
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 70518417200

NDC 970518-4172
NDC 1070518-4172-0
NDC Item70518417200
Packaging8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-0)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id807843
Imprint codeTP;500
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-30
Marketing statusactive
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 70518417201

NDC 970518-4172
NDC 1070518-4172-1
NDC Item70518417201
Packaging10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id807843
Imprint codeTP;500
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-30
Marketing statusactive
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 00054034807

NDC 90054-0348
NDC 100054-0348-07
NDC Item00054034807
Packaging20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07)
ANDAANDA201172
COLORTEXTWHITE(Off White)
ColorC48325 __
FDA SPL set id611868
Imprint code54455
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-10-31
Marketing effective time low2012-04-30
Marketing statusCOMPLETED
Score2
ShapetextModified
ShapeC48345
Size16 mm
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NDC Item 00054034821

NDC 90054-0348
NDC 100054-0348-21
NDC Item00054034821
Packaging60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21)
ANDAANDA201172
COLORTEXTWHITE(Off White)
ColorC48325 __
FDA SPL set id611868
Imprint code54455
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-10-31
Marketing effective time low2012-04-30
Marketing statusCOMPLETED
Score2
ShapetextModified
ShapeC48345
Size16 mm
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NDC Item 16571021506

NDC 916571-215
NDC 1016571-215-06
NDC Item16571021506
Packaging60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06)
ANDAANDA202489
COLORTEXTPINK
ColorC48328 __
FDA SPL set id114445
Imprint codeTP;500
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-10
Marketing effective time low2013-10-09
Marketing statusCOMPLETED
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 42799020801

NDC 942799-208
NDC 1042799-208-01
NDC Item42799020801
Packaging20 TABLET in 1 BOTTLE (42799-208-01)
ANDAANDA203808
COLORTEXTYELLOW
ColorC48330 __
FDA SPL set id624893
Imprint code208
LabelerEdenbridge Pharmaceuticals LLC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-12-20
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 42799020802

NDC 942799-208
NDC 1042799-208-02
NDC Item42799020802
Packaging60 TABLET in 1 BOTTLE (42799-208-02)
ANDAANDA203808
COLORTEXTYELLOW
ColorC48330 __
FDA SPL set id624893
Imprint code208
LabelerEdenbridge Pharmaceuticals LLC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-12-20
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 43386055102

NDC 943386-551
NDC 1043386-551-02
NDC Item43386055102
Packaging20 TABLET in 1 BOTTLE (43386-551-02)
ANDAANDA202044
COLORTEXTPINK
ColorC48328 __
FDA SPL set id716141
Imprint codeNL;551
LabelerLupin Pharmaceuticals,Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 43386055106

NDC 943386-551
NDC 1043386-551-06
NDC Item43386055106
Packaging60 TABLET in 1 BOTTLE (43386-551-06)
ANDAANDA202044
COLORTEXTPINK
ColorC48328 __
FDA SPL set id716141
Imprint codeNL;551
LabelerLupin Pharmaceuticals,Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 44523045020

NDC 944523-450
NDC 1044523-450-20
NDC Item44523045020
Packaging20 TABLET in 1 BOTTLE (44523-450-20)
COLORTEXTPINK
ColorC48328 __
FDA SPL set id71195
Imprint codeTM;500
LabelerBiocomp Pharma, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA AUTHORIZED GENERIC
Marketing effective time high2019-02-05
Marketing effective time low2012-06-07
Marketing statusCOMPLETED
NDA_AUTHORIZED_GENERICNDA021618
Score2
ShapeC48345
Size14 mm
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NDC Item 62135083520

NDC 962135-835
NDC 1062135-835-20
NDC Item62135083520
Packaging20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20)
ANDAANDA202044
COLORTEXTwhite(white to off-white)
ColorC48325 __
FDA SPL set id798224
Imprint codeC;E;205
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusactive
Score2
ShapeC48345
Size16 mm
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NDC Item 64980042712

NDC 964980-427
NDC 1064980-427-12
NDC Item64980042712
Packaging12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12)
ANDAANDA202489
COLORTEXTPINK
ColorC48328 __
FDA SPL set id717670
Imprint codeTP;500
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-10-09
Marketing statusACTIVE
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 67296183608

NDC 967296-1836
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ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id798328
Imprint codeTP;500
LabelerRedpharm Drug, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-10-09
Marketing statusACTIVE
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 70518417200

NDC 970518-4172
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ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id807843
Imprint codeTP;500
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-30
Marketing statusactive
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC 970518-4172
NDC 1070518-4172-1
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Packaging10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id807843
Imprint codeTP;500
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-30
Marketing statusactive
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 00054034807

NDC 90054-0348
NDC 100054-0348-07
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Packaging20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07)
ANDAANDA201172
COLORTEXTWHITE(Off White)
ColorC48325 __
FDA SPL set id611868
Imprint code54455
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-10-31
Marketing effective time low2012-04-30
Marketing statusCOMPLETED
Score2
ShapetextModified
ShapeC48345
Size16 mm
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NDC Item 00054034821

NDC 90054-0348
NDC 100054-0348-21
NDC Item00054034821
Packaging60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21)
ANDAANDA201172
COLORTEXTWHITE(Off White)
ColorC48325 __
FDA SPL set id611868
Imprint code54455
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-10-31
Marketing effective time low2012-04-30
Marketing statusCOMPLETED
Score2
ShapetextModified
ShapeC48345
Size16 mm
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NDC Item 16571021506

NDC 916571-215
NDC 1016571-215-06
NDC Item16571021506
Packaging60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06)
ANDAANDA202489
COLORTEXTPINK
ColorC48328 __
FDA SPL set id114445
Imprint codeTP;500
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-10
Marketing effective time low2013-10-09
Marketing statusCOMPLETED
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 42799020801

NDC 942799-208
NDC 1042799-208-01
NDC Item42799020801
Packaging20 TABLET in 1 BOTTLE (42799-208-01)
ANDAANDA203808
COLORTEXTYELLOW
ColorC48330 __
FDA SPL set id624893
Imprint code208
LabelerEdenbridge Pharmaceuticals LLC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-12-20
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 42799020802

NDC 942799-208
NDC 1042799-208-02
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Packaging60 TABLET in 1 BOTTLE (42799-208-02)
ANDAANDA203808
COLORTEXTYELLOW
ColorC48330 __
FDA SPL set id624893
Imprint code208
LabelerEdenbridge Pharmaceuticals LLC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-12-20
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 43386055102

NDC 943386-551
NDC 1043386-551-02
NDC Item43386055102
Packaging20 TABLET in 1 BOTTLE (43386-551-02)
ANDAANDA202044
COLORTEXTPINK
ColorC48328 __
FDA SPL set id716141
Imprint codeNL;551
LabelerLupin Pharmaceuticals,Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 43386055106

NDC 943386-551
NDC 1043386-551-06
NDC Item43386055106
Packaging60 TABLET in 1 BOTTLE (43386-551-06)
ANDAANDA202044
COLORTEXTPINK
ColorC48328 __
FDA SPL set id716141
Imprint codeNL;551
LabelerLupin Pharmaceuticals,Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 44523045020

NDC 944523-450
NDC 1044523-450-20
NDC Item44523045020
Packaging20 TABLET in 1 BOTTLE (44523-450-20)
COLORTEXTPINK
ColorC48328 __
FDA SPL set id71195
Imprint codeTM;500
LabelerBiocomp Pharma, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA AUTHORIZED GENERIC
Marketing effective time high2019-02-05
Marketing effective time low2012-06-07
Marketing statusCOMPLETED
NDA_AUTHORIZED_GENERICNDA021618
Score2
ShapeC48345
Size14 mm
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NDC Item 62135083520

NDC 962135-835
NDC 1062135-835-20
NDC Item62135083520
Packaging20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20)
ANDAANDA202044
COLORTEXTwhite(white to off-white)
ColorC48325 __
FDA SPL set id798224
Imprint codeC;E;205
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusactive
Score2
ShapeC48345
Size16 mm
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NDC Item 64980042712

NDC 964980-427
NDC 1064980-427-12
NDC Item64980042712
Packaging12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12)
ANDAANDA202489
COLORTEXTPINK
ColorC48328 __
FDA SPL set id717670
Imprint codeTP;500
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-10-09
Marketing statusACTIVE
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 67296183608

NDC 967296-1836
NDC 1067296-1836-8
NDC Item67296183608
Packaging8 TABLET, FILM COATED in 1 BOTTLE (67296-1836-8)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id798328
Imprint codeTP;500
LabelerRedpharm Drug, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-10-09
Marketing statusACTIVE
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 70518417200

NDC 970518-4172
NDC 1070518-4172-0
NDC Item70518417200
Packaging8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-0)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id807843
Imprint codeTP;500
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-30
Marketing statusactive
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 70518417201

NDC 970518-4172
NDC 1070518-4172-1
NDC Item70518417201
Packaging10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id807843
Imprint codeTP;500
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-30
Marketing statusactive
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 00054034807

NDC 90054-0348
NDC 100054-0348-07
NDC Item00054034807
Packaging20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07)
ANDAANDA201172
COLORTEXTWHITE(Off White)
ColorC48325 __
FDA SPL set id611868
Imprint code54455
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-10-31
Marketing effective time low2012-04-30
Marketing statusCOMPLETED
Score2
ShapetextModified
ShapeC48345
Size16 mm
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NDC Item 00054034821

NDC 90054-0348
NDC 100054-0348-21
NDC Item00054034821
Packaging60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21)
ANDAANDA201172
COLORTEXTWHITE(Off White)
ColorC48325 __
FDA SPL set id611868
Imprint code54455
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-10-31
Marketing effective time low2012-04-30
Marketing statusCOMPLETED
Score2
ShapetextModified
ShapeC48345
Size16 mm
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NDC Item 16571021506

NDC 916571-215
NDC 1016571-215-06
NDC Item16571021506
Packaging60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06)
ANDAANDA202489
COLORTEXTPINK
ColorC48328 __
FDA SPL set id114445
Imprint codeTP;500
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-10
Marketing effective time low2013-10-09
Marketing statusCOMPLETED
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 42799020801

NDC 942799-208
NDC 1042799-208-01
NDC Item42799020801
Packaging20 TABLET in 1 BOTTLE (42799-208-01)
ANDAANDA203808
COLORTEXTYELLOW
ColorC48330 __
FDA SPL set id624893
Imprint code208
LabelerEdenbridge Pharmaceuticals LLC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-12-20
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 42799020802

NDC 942799-208
NDC 1042799-208-02
NDC Item42799020802
Packaging60 TABLET in 1 BOTTLE (42799-208-02)
ANDAANDA203808
COLORTEXTYELLOW
ColorC48330 __
FDA SPL set id624893
Imprint code208
LabelerEdenbridge Pharmaceuticals LLC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-12-20
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 43386055102

NDC 943386-551
NDC 1043386-551-02
NDC Item43386055102
Packaging20 TABLET in 1 BOTTLE (43386-551-02)
ANDAANDA202044
COLORTEXTPINK
ColorC48328 __
FDA SPL set id716141
Imprint codeNL;551
LabelerLupin Pharmaceuticals,Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 43386055106

NDC 943386-551
NDC 1043386-551-06
NDC Item43386055106
Packaging60 TABLET in 1 BOTTLE (43386-551-06)
ANDAANDA202044
COLORTEXTPINK
ColorC48328 __
FDA SPL set id716141
Imprint codeNL;551
LabelerLupin Pharmaceuticals,Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 44523045020

NDC 944523-450
NDC 1044523-450-20
NDC Item44523045020
Packaging20 TABLET in 1 BOTTLE (44523-450-20)
COLORTEXTPINK
ColorC48328 __
FDA SPL set id71195
Imprint codeTM;500
LabelerBiocomp Pharma, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA AUTHORIZED GENERIC
Marketing effective time high2019-02-05
Marketing effective time low2012-06-07
Marketing statusCOMPLETED
NDA_AUTHORIZED_GENERICNDA021618
Score2
ShapeC48345
Size14 mm
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NDC Item 62135083520

NDC 962135-835
NDC 1062135-835-20
NDC Item62135083520
Packaging20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20)
ANDAANDA202044
COLORTEXTwhite(white to off-white)
ColorC48325 __
FDA SPL set id798224
Imprint codeC;E;205
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusactive
Score2
ShapeC48345
Size16 mm
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NDC Item 64980042712

NDC 964980-427
NDC 1064980-427-12
NDC Item64980042712
Packaging12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12)
ANDAANDA202489
COLORTEXTPINK
ColorC48328 __
FDA SPL set id717670
Imprint codeTP;500
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-10-09
Marketing statusACTIVE
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 67296183608

NDC 967296-1836
NDC 1067296-1836-8
NDC Item67296183608
Packaging8 TABLET, FILM COATED in 1 BOTTLE (67296-1836-8)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id798328
Imprint codeTP;500
LabelerRedpharm Drug, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-10-09
Marketing statusACTIVE
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 70518417200

NDC 970518-4172
NDC 1070518-4172-0
NDC Item70518417200
Packaging8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-0)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id807843
Imprint codeTP;500
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-30
Marketing statusactive
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 70518417201

NDC 970518-4172
NDC 1070518-4172-1
NDC Item70518417201
Packaging10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id807843
Imprint codeTP;500
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-30
Marketing statusactive
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 00054034807

NDC 90054-0348
NDC 100054-0348-07
NDC Item00054034807
Packaging20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07)
ANDAANDA201172
COLORTEXTWHITE(Off White)
ColorC48325 __
FDA SPL set id611868
Imprint code54455
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-10-31
Marketing effective time low2012-04-30
Marketing statusCOMPLETED
Score2
ShapetextModified
ShapeC48345
Size16 mm
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NDC Item 00054034821

NDC 90054-0348
NDC 100054-0348-21
NDC Item00054034821
Packaging60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21)
ANDAANDA201172
COLORTEXTWHITE(Off White)
ColorC48325 __
FDA SPL set id611868
Imprint code54455
LabelerHikma Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2021-10-31
Marketing effective time low2012-04-30
Marketing statusCOMPLETED
Score2
ShapetextModified
ShapeC48345
Size16 mm
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NDC Item 16571021506

NDC 916571-215
NDC 1016571-215-06
NDC Item16571021506
Packaging60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06)
ANDAANDA202489
COLORTEXTPINK
ColorC48328 __
FDA SPL set id114445
Imprint codeTP;500
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time high2013-10-10
Marketing effective time low2013-10-09
Marketing statusCOMPLETED
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
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NDC Item 42799020801

NDC 942799-208
NDC 1042799-208-01
NDC Item42799020801
Packaging20 TABLET in 1 BOTTLE (42799-208-01)
ANDAANDA203808
COLORTEXTYELLOW
ColorC48330 __
FDA SPL set id624893
Imprint code208
LabelerEdenbridge Pharmaceuticals LLC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-12-20
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 42799020802

NDC 942799-208
NDC 1042799-208-02
NDC Item42799020802
Packaging60 TABLET in 1 BOTTLE (42799-208-02)
ANDAANDA203808
COLORTEXTYELLOW
ColorC48330 __
FDA SPL set id624893
Imprint code208
LabelerEdenbridge Pharmaceuticals LLC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2019-12-20
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 43386055102

NDC 943386-551
NDC 1043386-551-02
NDC Item43386055102
Packaging20 TABLET in 1 BOTTLE (43386-551-02)
ANDAANDA202044
COLORTEXTPINK
ColorC48328 __
FDA SPL set id716141
Imprint codeNL;551
LabelerLupin Pharmaceuticals,Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 43386055106

NDC 943386-551
NDC 1043386-551-06
NDC Item43386055106
Packaging60 TABLET in 1 BOTTLE (43386-551-06)
ANDAANDA202044
COLORTEXTPINK
ColorC48328 __
FDA SPL set id716141
Imprint codeNL;551
LabelerLupin Pharmaceuticals,Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusACTIVE
Score2
ShapeC48345
Size16 mm
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NDC Item 44523045020

NDC 944523-450
NDC 1044523-450-20
NDC Item44523045020
Packaging20 TABLET in 1 BOTTLE (44523-450-20)
COLORTEXTPINK
ColorC48328 __
FDA SPL set id71195
Imprint codeTM;500
LabelerBiocomp Pharma, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryNDA AUTHORIZED GENERIC
Marketing effective time high2019-02-05
Marketing effective time low2012-06-07
Marketing statusCOMPLETED
NDA_AUTHORIZED_GENERICNDA021618
Score2
ShapeC48345
Size14 mm
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NDC Item 62135083520

NDC 962135-835
NDC 1062135-835-20
NDC Item62135083520
Packaging20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20)
ANDAANDA202044
COLORTEXTwhite(white to off-white)
ColorC48325 __
FDA SPL set id798224
Imprint codeC;E;205
LabelerChartwell RX, LLC
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2012-04-30
Marketing statusactive
Score2
ShapeC48345
Size16 mm
Related queriesProperties for NDC 9 62135-835

NDC Item 64980042712

NDC 964980-427
NDC 1064980-427-12
NDC Item64980042712
Packaging12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12)
ANDAANDA202489
COLORTEXTPINK
ColorC48328 __
FDA SPL set id717670
Imprint codeTP;500
LabelerRising Pharma Holdings, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-10-09
Marketing statusACTIVE
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 64980-427

NDC Item 67296183608

NDC 967296-1836
NDC 1067296-1836-8
NDC Item67296183608
Packaging8 TABLET, FILM COATED in 1 BOTTLE (67296-1836-8)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id798328
Imprint codeTP;500
LabelerRedpharm Drug, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2013-10-09
Marketing statusACTIVE
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 67296-1836

NDC Item 70518417200

NDC 970518-4172
NDC 1070518-4172-0
NDC Item70518417200
Packaging8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-0)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id807843
Imprint codeTP;500
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-30
Marketing statusactive
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 70518-4172

NDC Item 70518417201

NDC 970518-4172
NDC 1070518-4172-1
NDC Item70518417201
Packaging10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1)
ANDAANDA202489
COLORTEXTpink
ColorC48328 __
FDA SPL set id807843
Imprint codeTP;500
LabelerREMEDYREPACK INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-08-30
Marketing statusactive
Score2
ShapetextCapsule Shaped
ShapeC48336
Size16 mm
Related queriesProperties for NDC 9 70518-4172