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HomeSearchRxCUI 643720: Brands

NDC properties for "lenalidomide 25 MG Oral Capsule" (RxCUI 643720)

About this data

The tables show NDC propoerties for lenalidomide 25 MG Oral Capsule with the RxCUI 643720

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 lenalidomide 25 MG Oral Capsule (RxCUI 643720)

ANDAANDA201452
ANDAANDA209348
ANDAANDA210154
ANDAANDA210435
ANDAANDA210480
ANDAANDA211022
ANDAANDA211846
ANDAANDA212414
ANDAANDA213885
ANDAANDA213912
MMSL_CODEBD16978
MMSL_CODECD16978
RxCUI643720
SNOMEDCT840662000
SPL_SET_ID1b2716cf-24b4-4157-a218-58ede63917bd
SPL_SET_ID51bfdd53-8fd9-4f86-bebe-75de29e6379d
SPL_SET_ID682e8a86-9f49-45db-a2ea-403ee1dc62d2
SPL_SET_ID76f6c1e7-985b-43d9-892c-849df50ae80e
SPL_SET_ID84d9dec7-9250-4dbd-9a0d-23e75f111892
SPL_SET_ID9943e098-20b0-dbb3-af12-7816eedd3f70
SPL_SET_IDadee5af1-c9ab-c0c7-e400-dea7d2a0d4be
SPL_SET_IDba2a07fd-ca60-40bc-b79b-9caf81900fa3
SPL_SET_IDc98fb504-76d0-4c25-9c0b-412885828a7a
SPL_SET_IDca8cc2cc-c856-e676-4f60-1e46d7b53d73
SPL_SET_IDf27092f3-3977-4f4a-b214-45309e136e46
SPL_SET_IDfd23328f-b019-4c14-80d9-4ebd997f26b2
VUID4025613
Prescribable Synonymlenalidomide 25 MG Oral Capsule
RXNAV_STRlenalidomide 25 MG Oral Capsule
RxNorm Namelenalidomide 25 MG Oral Capsule
Related queriesInteractions (for RxCUI 643720)



NDC Properties

NDC Item 00378194001

NDC 90378-1940
NDC 100378-1940-01
NDC Item00378194001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 0378-1940

NDC Item 00378194021

NDC 90378-1940
NDC 100378-1940-21
NDC Item00378194021
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 0378-1940

NDC Item 00480124621

NDC 90480-1246
NDC 100480-1246-21
NDC Item00480124621
Packaging21 CAPSULE in 1 BOTTLE (0480-1246-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;25mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-03-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 0480-1246

NDC Item 31722026201

NDC 931722-262
NDC 1031722-262-01
NDC Item31722026201
Packaging100 CAPSULE in 1 BOTTLE (31722-262-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 31722-262

NDC Item 31722026221

NDC 931722-262
NDC 1031722-262-21
NDC Item31722026221
Packaging21 CAPSULE in 1 BOTTLE (31722-262-21)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 31722-262

NDC Item 43598051501

NDC 943598-515
NDC 1043598-515-01
NDC Item43598051501
Packaging100 CAPSULE in 1 BOTTLE (43598-515-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 43598-515

NDC Item 43598051521

NDC 943598-515
NDC 1043598-515-21
NDC Item43598051521
Packaging21 CAPSULE in 1 BOTTLE (43598-515-21)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 43598-515

NDC Item 47781048801

NDC 947781-488
NDC 1047781-488-01
NDC Item47781048801
Packaging100 CAPSULE in 1 BOTTLE (47781-488-01)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 47781-488

NDC Item 47781048877

NDC 947781-488
NDC 1047781-488-77
NDC Item47781048877
Packaging21 CAPSULE in 1 BOTTLE (47781-488-77)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 47781-488

NDC Item 59651034701

NDC 959651-347
NDC 1059651-347-01
NDC Item59651034701
Packaging100 CAPSULE in 1 BOTTLE (59651-347-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 59651-347

NDC Item 59651034707

NDC 959651-347
NDC 1059651-347-07
NDC Item59651034707
Packaging1 BLISTER PACK in 1 CARTON (59651-347-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 59651-347

NDC Item 59651034721

NDC 959651-347
NDC 1059651-347-21
NDC Item59651034721
Packaging21 CAPSULE in 1 BOTTLE (59651-347-21)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 59651-347

NDC Item 60505453701

NDC 960505-4537
NDC 1060505-4537-1
NDC Item60505453701
Packaging100 CAPSULE in 1 BOTTLE (60505-4537-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 60505-4537

NDC Item 60505453702

NDC 960505-4537
NDC 1060505-4537-2
NDC Item60505453702
Packaging21 CAPSULE in 1 BOTTLE (60505-4537-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 60505-4537

NDC Item 63304004601

NDC 963304-046
NDC 1063304-046-01
NDC Item63304004601
Packaging100 CAPSULE in 1 BOTTLE (63304-046-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 63304-046

NDC Item 63304004622

NDC 963304-046
NDC 1063304-046-22
NDC Item63304004622
Packaging21 CAPSULE in 1 BOTTLE (63304-046-22)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 63304-046

NDC Item 69097038581

NDC 969097-385
NDC 1069097-385-81
NDC Item69097038581
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-385-81)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla25mg;385
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 69097-385

NDC Item 70710103501

NDC 970710-1035
NDC 1070710-1035-1
NDC Item70710103501
Packaging100 CAPSULE in 1 BOTTLE (70710-1035-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 70710-1035

NDC Item 70710103508

NDC 970710-1035
NDC 1070710-1035-8
NDC Item70710103508
Packaging21 CAPSULE in 1 BOTTLE (70710-1035-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 70710-1035

NDC Item 70771168101

NDC 970771-1681
NDC 1070771-1681-1
NDC Item70771168101
Packaging100 CAPSULE in 1 BOTTLE (70771-1681-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 70771-1681

NDC Item 70771168108

NDC 970771-1681
NDC 1070771-1681-8
NDC Item70771168108
Packaging21 CAPSULE in 1 BOTTLE (70771-1681-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 70771-1681

NDC Item 76282070147

NDC 976282-701
NDC 1076282-701-47
NDC Item76282070147
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-701-47)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id655779
Imprint codeCipla25mg;385
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 76282-701

NDC Item 00378194001

NDC 90378-1940
NDC 100378-1940-01
NDC Item00378194001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 0378-1940

NDC Item 00378194021

NDC 90378-1940
NDC 100378-1940-21
NDC Item00378194021
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 0378-1940

NDC Item 00480124621

NDC 90480-1246
NDC 100480-1246-21
NDC Item00480124621
Packaging21 CAPSULE in 1 BOTTLE (0480-1246-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;25mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-03-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 0480-1246

NDC Item 31722026201

NDC 931722-262
NDC 1031722-262-01
NDC Item31722026201
Packaging100 CAPSULE in 1 BOTTLE (31722-262-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 31722-262

NDC Item 31722026221

NDC 931722-262
NDC 1031722-262-21
NDC Item31722026221
Packaging21 CAPSULE in 1 BOTTLE (31722-262-21)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 31722-262

NDC Item 43598051501

NDC 943598-515
NDC 1043598-515-01
NDC Item43598051501
Packaging100 CAPSULE in 1 BOTTLE (43598-515-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 43598-515

NDC Item 43598051521

NDC 943598-515
NDC 1043598-515-21
NDC Item43598051521
Packaging21 CAPSULE in 1 BOTTLE (43598-515-21)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 43598-515

NDC Item 47781048801

NDC 947781-488
NDC 1047781-488-01
NDC Item47781048801
Packaging100 CAPSULE in 1 BOTTLE (47781-488-01)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 47781-488

NDC Item 47781048877

NDC 947781-488
NDC 1047781-488-77
NDC Item47781048877
Packaging21 CAPSULE in 1 BOTTLE (47781-488-77)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 47781-488

NDC Item 59651034701

NDC 959651-347
NDC 1059651-347-01
NDC Item59651034701
Packaging100 CAPSULE in 1 BOTTLE (59651-347-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 59651-347

NDC Item 59651034707

NDC 959651-347
NDC 1059651-347-07
NDC Item59651034707
Packaging1 BLISTER PACK in 1 CARTON (59651-347-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 59651-347

NDC Item 59651034721

NDC 959651-347
NDC 1059651-347-21
NDC Item59651034721
Packaging21 CAPSULE in 1 BOTTLE (59651-347-21)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 59651-347

NDC Item 60505453701

NDC 960505-4537
NDC 1060505-4537-1
NDC Item60505453701
Packaging100 CAPSULE in 1 BOTTLE (60505-4537-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 60505-4537

NDC Item 60505453702

NDC 960505-4537
NDC 1060505-4537-2
NDC Item60505453702
Packaging21 CAPSULE in 1 BOTTLE (60505-4537-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 60505-4537

NDC Item 63304004601

NDC 963304-046
NDC 1063304-046-01
NDC Item63304004601
Packaging100 CAPSULE in 1 BOTTLE (63304-046-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 63304-046

NDC Item 63304004622

NDC 963304-046
NDC 1063304-046-22
NDC Item63304004622
Packaging21 CAPSULE in 1 BOTTLE (63304-046-22)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 63304-046

NDC Item 69097038581

NDC 969097-385
NDC 1069097-385-81
NDC Item69097038581
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-385-81)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla25mg;385
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 69097-385

NDC Item 70710103501

NDC 970710-1035
NDC 1070710-1035-1
NDC Item70710103501
Packaging100 CAPSULE in 1 BOTTLE (70710-1035-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70710103508

NDC 970710-1035
NDC 1070710-1035-8
NDC Item70710103508
Packaging21 CAPSULE in 1 BOTTLE (70710-1035-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168101

NDC 970771-1681
NDC 1070771-1681-1
NDC Item70771168101
Packaging100 CAPSULE in 1 BOTTLE (70771-1681-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168108

NDC 970771-1681
NDC 1070771-1681-8
NDC Item70771168108
Packaging21 CAPSULE in 1 BOTTLE (70771-1681-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 76282070147

NDC 976282-701
NDC 1076282-701-47
NDC Item76282070147
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-701-47)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id655779
Imprint codeCipla25mg;385
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194001

NDC 90378-1940
NDC 100378-1940-01
NDC Item00378194001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194021

NDC 90378-1940
NDC 100378-1940-21
NDC Item00378194021
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124621

NDC 90480-1246
NDC 100480-1246-21
NDC Item00480124621
Packaging21 CAPSULE in 1 BOTTLE (0480-1246-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;25mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-03-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722026201

NDC 931722-262
NDC 1031722-262-01
NDC Item31722026201
Packaging100 CAPSULE in 1 BOTTLE (31722-262-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026221

NDC 931722-262
NDC 1031722-262-21
NDC Item31722026221
Packaging21 CAPSULE in 1 BOTTLE (31722-262-21)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051501

NDC 943598-515
NDC 1043598-515-01
NDC Item43598051501
Packaging100 CAPSULE in 1 BOTTLE (43598-515-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 43598051521

NDC 943598-515
NDC 1043598-515-21
NDC Item43598051521
Packaging21 CAPSULE in 1 BOTTLE (43598-515-21)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 47781048801

NDC 947781-488
NDC 1047781-488-01
NDC Item47781048801
Packaging100 CAPSULE in 1 BOTTLE (47781-488-01)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 47781048877

NDC 947781-488
NDC 1047781-488-77
NDC Item47781048877
Packaging21 CAPSULE in 1 BOTTLE (47781-488-77)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 59651034701

NDC 959651-347
NDC 1059651-347-01
NDC Item59651034701
Packaging100 CAPSULE in 1 BOTTLE (59651-347-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034707

NDC 959651-347
NDC 1059651-347-07
NDC Item59651034707
Packaging1 BLISTER PACK in 1 CARTON (59651-347-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034721

NDC 959651-347
NDC 1059651-347-21
NDC Item59651034721
Packaging21 CAPSULE in 1 BOTTLE (59651-347-21)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453701

NDC 960505-4537
NDC 1060505-4537-1
NDC Item60505453701
Packaging100 CAPSULE in 1 BOTTLE (60505-4537-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 60505453702

NDC 960505-4537
NDC 1060505-4537-2
NDC Item60505453702
Packaging21 CAPSULE in 1 BOTTLE (60505-4537-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 63304004601

NDC 963304-046
NDC 1063304-046-01
NDC Item63304004601
Packaging100 CAPSULE in 1 BOTTLE (63304-046-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004622

NDC 963304-046
NDC 1063304-046-22
NDC Item63304004622
Packaging21 CAPSULE in 1 BOTTLE (63304-046-22)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038581

NDC 969097-385
NDC 1069097-385-81
NDC Item69097038581
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-385-81)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla25mg;385
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 70710103501

NDC 970710-1035
NDC 1070710-1035-1
NDC Item70710103501
Packaging100 CAPSULE in 1 BOTTLE (70710-1035-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70710103508

NDC 970710-1035
NDC 1070710-1035-8
NDC Item70710103508
Packaging21 CAPSULE in 1 BOTTLE (70710-1035-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168101

NDC 970771-1681
NDC 1070771-1681-1
NDC Item70771168101
Packaging100 CAPSULE in 1 BOTTLE (70771-1681-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168108

NDC 970771-1681
NDC 1070771-1681-8
NDC Item70771168108
Packaging21 CAPSULE in 1 BOTTLE (70771-1681-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 76282070147

NDC 976282-701
NDC 1076282-701-47
NDC Item76282070147
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-701-47)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id655779
Imprint codeCipla25mg;385
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194001

NDC 90378-1940
NDC 100378-1940-01
NDC Item00378194001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194021

NDC 90378-1940
NDC 100378-1940-21
NDC Item00378194021
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124621

NDC 90480-1246
NDC 100480-1246-21
NDC Item00480124621
Packaging21 CAPSULE in 1 BOTTLE (0480-1246-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;25mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-03-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722026201

NDC 931722-262
NDC 1031722-262-01
NDC Item31722026201
Packaging100 CAPSULE in 1 BOTTLE (31722-262-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026221

NDC 931722-262
NDC 1031722-262-21
NDC Item31722026221
Packaging21 CAPSULE in 1 BOTTLE (31722-262-21)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051501

NDC 943598-515
NDC 1043598-515-01
NDC Item43598051501
Packaging100 CAPSULE in 1 BOTTLE (43598-515-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 43598051521

NDC 943598-515
NDC 1043598-515-21
NDC Item43598051521
Packaging21 CAPSULE in 1 BOTTLE (43598-515-21)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 47781048801

NDC 947781-488
NDC 1047781-488-01
NDC Item47781048801
Packaging100 CAPSULE in 1 BOTTLE (47781-488-01)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 47781048877

NDC 947781-488
NDC 1047781-488-77
NDC Item47781048877
Packaging21 CAPSULE in 1 BOTTLE (47781-488-77)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 59651034701

NDC 959651-347
NDC 1059651-347-01
NDC Item59651034701
Packaging100 CAPSULE in 1 BOTTLE (59651-347-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034707

NDC 959651-347
NDC 1059651-347-07
NDC Item59651034707
Packaging1 BLISTER PACK in 1 CARTON (59651-347-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034721

NDC 959651-347
NDC 1059651-347-21
NDC Item59651034721
Packaging21 CAPSULE in 1 BOTTLE (59651-347-21)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453701

NDC 960505-4537
NDC 1060505-4537-1
NDC Item60505453701
Packaging100 CAPSULE in 1 BOTTLE (60505-4537-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 60505453702

NDC 960505-4537
NDC 1060505-4537-2
NDC Item60505453702
Packaging21 CAPSULE in 1 BOTTLE (60505-4537-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 63304004601

NDC 963304-046
NDC 1063304-046-01
NDC Item63304004601
Packaging100 CAPSULE in 1 BOTTLE (63304-046-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004622

NDC 963304-046
NDC 1063304-046-22
NDC Item63304004622
Packaging21 CAPSULE in 1 BOTTLE (63304-046-22)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038581

NDC 969097-385
NDC 1069097-385-81
NDC Item69097038581
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-385-81)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla25mg;385
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 70710103501

NDC 970710-1035
NDC 1070710-1035-1
NDC Item70710103501
Packaging100 CAPSULE in 1 BOTTLE (70710-1035-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70710103508

NDC 970710-1035
NDC 1070710-1035-8
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Packaging21 CAPSULE in 1 BOTTLE (70710-1035-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168101

NDC 970771-1681
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Packaging100 CAPSULE in 1 BOTTLE (70771-1681-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168108

NDC 970771-1681
NDC 1070771-1681-8
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Packaging21 CAPSULE in 1 BOTTLE (70771-1681-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 76282070147

NDC 976282-701
NDC 1076282-701-47
NDC Item76282070147
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-701-47)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id655779
Imprint codeCipla25mg;385
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194001

NDC 90378-1940
NDC 100378-1940-01
NDC Item00378194001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194021

NDC 90378-1940
NDC 100378-1940-21
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Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124621

NDC 90480-1246
NDC 100480-1246-21
NDC Item00480124621
Packaging21 CAPSULE in 1 BOTTLE (0480-1246-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;25mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-03-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722026201

NDC 931722-262
NDC 1031722-262-01
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Packaging100 CAPSULE in 1 BOTTLE (31722-262-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026221

NDC 931722-262
NDC 1031722-262-21
NDC Item31722026221
Packaging21 CAPSULE in 1 BOTTLE (31722-262-21)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051501

NDC 943598-515
NDC 1043598-515-01
NDC Item43598051501
Packaging100 CAPSULE in 1 BOTTLE (43598-515-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 43598051521

NDC 943598-515
NDC 1043598-515-21
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Packaging21 CAPSULE in 1 BOTTLE (43598-515-21)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 47781048801

NDC 947781-488
NDC 1047781-488-01
NDC Item47781048801
Packaging100 CAPSULE in 1 BOTTLE (47781-488-01)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 47781048877

NDC 947781-488
NDC 1047781-488-77
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Packaging21 CAPSULE in 1 BOTTLE (47781-488-77)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 59651034701

NDC 959651-347
NDC 1059651-347-01
NDC Item59651034701
Packaging100 CAPSULE in 1 BOTTLE (59651-347-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034707

NDC 959651-347
NDC 1059651-347-07
NDC Item59651034707
Packaging1 BLISTER PACK in 1 CARTON (59651-347-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034721

NDC 959651-347
NDC 1059651-347-21
NDC Item59651034721
Packaging21 CAPSULE in 1 BOTTLE (59651-347-21)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453701

NDC 960505-4537
NDC 1060505-4537-1
NDC Item60505453701
Packaging100 CAPSULE in 1 BOTTLE (60505-4537-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 60505453702

NDC 960505-4537
NDC 1060505-4537-2
NDC Item60505453702
Packaging21 CAPSULE in 1 BOTTLE (60505-4537-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 63304004601

NDC 963304-046
NDC 1063304-046-01
NDC Item63304004601
Packaging100 CAPSULE in 1 BOTTLE (63304-046-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004622

NDC 963304-046
NDC 1063304-046-22
NDC Item63304004622
Packaging21 CAPSULE in 1 BOTTLE (63304-046-22)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038581

NDC 969097-385
NDC 1069097-385-81
NDC Item69097038581
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-385-81)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla25mg;385
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 70710103501

NDC 970710-1035
NDC 1070710-1035-1
NDC Item70710103501
Packaging100 CAPSULE in 1 BOTTLE (70710-1035-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70710103508

NDC 970710-1035
NDC 1070710-1035-8
NDC Item70710103508
Packaging21 CAPSULE in 1 BOTTLE (70710-1035-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168101

NDC 970771-1681
NDC 1070771-1681-1
NDC Item70771168101
Packaging100 CAPSULE in 1 BOTTLE (70771-1681-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168108

NDC 970771-1681
NDC 1070771-1681-8
NDC Item70771168108
Packaging21 CAPSULE in 1 BOTTLE (70771-1681-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 76282070147

NDC 976282-701
NDC 1076282-701-47
NDC Item76282070147
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-701-47)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id655779
Imprint codeCipla25mg;385
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194001

NDC 90378-1940
NDC 100378-1940-01
NDC Item00378194001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194021

NDC 90378-1940
NDC 100378-1940-21
NDC Item00378194021
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124621

NDC 90480-1246
NDC 100480-1246-21
NDC Item00480124621
Packaging21 CAPSULE in 1 BOTTLE (0480-1246-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;25mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-03-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722026201

NDC 931722-262
NDC 1031722-262-01
NDC Item31722026201
Packaging100 CAPSULE in 1 BOTTLE (31722-262-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026221

NDC 931722-262
NDC 1031722-262-21
NDC Item31722026221
Packaging21 CAPSULE in 1 BOTTLE (31722-262-21)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051501

NDC 943598-515
NDC 1043598-515-01
NDC Item43598051501
Packaging100 CAPSULE in 1 BOTTLE (43598-515-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 43598051521

NDC 943598-515
NDC 1043598-515-21
NDC Item43598051521
Packaging21 CAPSULE in 1 BOTTLE (43598-515-21)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 47781048801

NDC 947781-488
NDC 1047781-488-01
NDC Item47781048801
Packaging100 CAPSULE in 1 BOTTLE (47781-488-01)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 47781048877

NDC 947781-488
NDC 1047781-488-77
NDC Item47781048877
Packaging21 CAPSULE in 1 BOTTLE (47781-488-77)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 59651034701

NDC 959651-347
NDC 1059651-347-01
NDC Item59651034701
Packaging100 CAPSULE in 1 BOTTLE (59651-347-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034707

NDC 959651-347
NDC 1059651-347-07
NDC Item59651034707
Packaging1 BLISTER PACK in 1 CARTON (59651-347-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034721

NDC 959651-347
NDC 1059651-347-21
NDC Item59651034721
Packaging21 CAPSULE in 1 BOTTLE (59651-347-21)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453701

NDC 960505-4537
NDC 1060505-4537-1
NDC Item60505453701
Packaging100 CAPSULE in 1 BOTTLE (60505-4537-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 60505453702

NDC 960505-4537
NDC 1060505-4537-2
NDC Item60505453702
Packaging21 CAPSULE in 1 BOTTLE (60505-4537-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 63304004601

NDC 963304-046
NDC 1063304-046-01
NDC Item63304004601
Packaging100 CAPSULE in 1 BOTTLE (63304-046-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004622

NDC 963304-046
NDC 1063304-046-22
NDC Item63304004622
Packaging21 CAPSULE in 1 BOTTLE (63304-046-22)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038581

NDC 969097-385
NDC 1069097-385-81
NDC Item69097038581
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-385-81)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla25mg;385
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 70710103501

NDC 970710-1035
NDC 1070710-1035-1
NDC Item70710103501
Packaging100 CAPSULE in 1 BOTTLE (70710-1035-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70710103508

NDC 970710-1035
NDC 1070710-1035-8
NDC Item70710103508
Packaging21 CAPSULE in 1 BOTTLE (70710-1035-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168101

NDC 970771-1681
NDC 1070771-1681-1
NDC Item70771168101
Packaging100 CAPSULE in 1 BOTTLE (70771-1681-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168108

NDC 970771-1681
NDC 1070771-1681-8
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Packaging21 CAPSULE in 1 BOTTLE (70771-1681-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 76282070147

NDC 976282-701
NDC 1076282-701-47
NDC Item76282070147
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-701-47)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id655779
Imprint codeCipla25mg;385
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194001

NDC 90378-1940
NDC 100378-1940-01
NDC Item00378194001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194021

NDC 90378-1940
NDC 100378-1940-21
NDC Item00378194021
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124621

NDC 90480-1246
NDC 100480-1246-21
NDC Item00480124621
Packaging21 CAPSULE in 1 BOTTLE (0480-1246-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;25mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-03-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722026201

NDC 931722-262
NDC 1031722-262-01
NDC Item31722026201
Packaging100 CAPSULE in 1 BOTTLE (31722-262-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026221

NDC 931722-262
NDC 1031722-262-21
NDC Item31722026221
Packaging21 CAPSULE in 1 BOTTLE (31722-262-21)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051501

NDC 943598-515
NDC 1043598-515-01
NDC Item43598051501
Packaging100 CAPSULE in 1 BOTTLE (43598-515-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 43598051521

NDC 943598-515
NDC 1043598-515-21
NDC Item43598051521
Packaging21 CAPSULE in 1 BOTTLE (43598-515-21)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 47781048801

NDC 947781-488
NDC 1047781-488-01
NDC Item47781048801
Packaging100 CAPSULE in 1 BOTTLE (47781-488-01)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 47781048877

NDC 947781-488
NDC 1047781-488-77
NDC Item47781048877
Packaging21 CAPSULE in 1 BOTTLE (47781-488-77)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 59651034701

NDC 959651-347
NDC 1059651-347-01
NDC Item59651034701
Packaging100 CAPSULE in 1 BOTTLE (59651-347-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034707

NDC 959651-347
NDC 1059651-347-07
NDC Item59651034707
Packaging1 BLISTER PACK in 1 CARTON (59651-347-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034721

NDC 959651-347
NDC 1059651-347-21
NDC Item59651034721
Packaging21 CAPSULE in 1 BOTTLE (59651-347-21)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453701

NDC 960505-4537
NDC 1060505-4537-1
NDC Item60505453701
Packaging100 CAPSULE in 1 BOTTLE (60505-4537-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 60505453702

NDC 960505-4537
NDC 1060505-4537-2
NDC Item60505453702
Packaging21 CAPSULE in 1 BOTTLE (60505-4537-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 63304004601

NDC 963304-046
NDC 1063304-046-01
NDC Item63304004601
Packaging100 CAPSULE in 1 BOTTLE (63304-046-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004622

NDC 963304-046
NDC 1063304-046-22
NDC Item63304004622
Packaging21 CAPSULE in 1 BOTTLE (63304-046-22)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038581

NDC 969097-385
NDC 1069097-385-81
NDC Item69097038581
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-385-81)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla25mg;385
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 70710103501

NDC 970710-1035
NDC 1070710-1035-1
NDC Item70710103501
Packaging100 CAPSULE in 1 BOTTLE (70710-1035-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70710103508

NDC 970710-1035
NDC 1070710-1035-8
NDC Item70710103508
Packaging21 CAPSULE in 1 BOTTLE (70710-1035-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168101

NDC 970771-1681
NDC 1070771-1681-1
NDC Item70771168101
Packaging100 CAPSULE in 1 BOTTLE (70771-1681-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168108

NDC 970771-1681
NDC 1070771-1681-8
NDC Item70771168108
Packaging21 CAPSULE in 1 BOTTLE (70771-1681-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 76282070147

NDC 976282-701
NDC 1076282-701-47
NDC Item76282070147
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-701-47)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id655779
Imprint codeCipla25mg;385
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194001

NDC 90378-1940
NDC 100378-1940-01
NDC Item00378194001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194021

NDC 90378-1940
NDC 100378-1940-21
NDC Item00378194021
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124621

NDC 90480-1246
NDC 100480-1246-21
NDC Item00480124621
Packaging21 CAPSULE in 1 BOTTLE (0480-1246-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;25mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-03-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722026201

NDC 931722-262
NDC 1031722-262-01
NDC Item31722026201
Packaging100 CAPSULE in 1 BOTTLE (31722-262-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026221

NDC 931722-262
NDC 1031722-262-21
NDC Item31722026221
Packaging21 CAPSULE in 1 BOTTLE (31722-262-21)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051501

NDC 943598-515
NDC 1043598-515-01
NDC Item43598051501
Packaging100 CAPSULE in 1 BOTTLE (43598-515-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 43598051521

NDC 943598-515
NDC 1043598-515-21
NDC Item43598051521
Packaging21 CAPSULE in 1 BOTTLE (43598-515-21)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 47781048801

NDC 947781-488
NDC 1047781-488-01
NDC Item47781048801
Packaging100 CAPSULE in 1 BOTTLE (47781-488-01)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 47781048877

NDC 947781-488
NDC 1047781-488-77
NDC Item47781048877
Packaging21 CAPSULE in 1 BOTTLE (47781-488-77)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 59651034701

NDC 959651-347
NDC 1059651-347-01
NDC Item59651034701
Packaging100 CAPSULE in 1 BOTTLE (59651-347-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034707

NDC 959651-347
NDC 1059651-347-07
NDC Item59651034707
Packaging1 BLISTER PACK in 1 CARTON (59651-347-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034721

NDC 959651-347
NDC 1059651-347-21
NDC Item59651034721
Packaging21 CAPSULE in 1 BOTTLE (59651-347-21)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453701

NDC 960505-4537
NDC 1060505-4537-1
NDC Item60505453701
Packaging100 CAPSULE in 1 BOTTLE (60505-4537-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 60505453702

NDC 960505-4537
NDC 1060505-4537-2
NDC Item60505453702
Packaging21 CAPSULE in 1 BOTTLE (60505-4537-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 63304004601

NDC 963304-046
NDC 1063304-046-01
NDC Item63304004601
Packaging100 CAPSULE in 1 BOTTLE (63304-046-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004622

NDC 963304-046
NDC 1063304-046-22
NDC Item63304004622
Packaging21 CAPSULE in 1 BOTTLE (63304-046-22)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038581

NDC 969097-385
NDC 1069097-385-81
NDC Item69097038581
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-385-81)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla25mg;385
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 70710103501

NDC 970710-1035
NDC 1070710-1035-1
NDC Item70710103501
Packaging100 CAPSULE in 1 BOTTLE (70710-1035-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70710103508

NDC 970710-1035
NDC 1070710-1035-8
NDC Item70710103508
Packaging21 CAPSULE in 1 BOTTLE (70710-1035-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168101

NDC 970771-1681
NDC 1070771-1681-1
NDC Item70771168101
Packaging100 CAPSULE in 1 BOTTLE (70771-1681-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168108

NDC 970771-1681
NDC 1070771-1681-8
NDC Item70771168108
Packaging21 CAPSULE in 1 BOTTLE (70771-1681-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 76282070147

NDC 976282-701
NDC 1076282-701-47
NDC Item76282070147
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-701-47)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id655779
Imprint codeCipla25mg;385
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194001

NDC 90378-1940
NDC 100378-1940-01
NDC Item00378194001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194021

NDC 90378-1940
NDC 100378-1940-21
NDC Item00378194021
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124621

NDC 90480-1246
NDC 100480-1246-21
NDC Item00480124621
Packaging21 CAPSULE in 1 BOTTLE (0480-1246-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;25mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-03-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722026201

NDC 931722-262
NDC 1031722-262-01
NDC Item31722026201
Packaging100 CAPSULE in 1 BOTTLE (31722-262-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026221

NDC 931722-262
NDC 1031722-262-21
NDC Item31722026221
Packaging21 CAPSULE in 1 BOTTLE (31722-262-21)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051501

NDC 943598-515
NDC 1043598-515-01
NDC Item43598051501
Packaging100 CAPSULE in 1 BOTTLE (43598-515-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 43598051521

NDC 943598-515
NDC 1043598-515-21
NDC Item43598051521
Packaging21 CAPSULE in 1 BOTTLE (43598-515-21)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 47781048801

NDC 947781-488
NDC 1047781-488-01
NDC Item47781048801
Packaging100 CAPSULE in 1 BOTTLE (47781-488-01)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 47781048877

NDC 947781-488
NDC 1047781-488-77
NDC Item47781048877
Packaging21 CAPSULE in 1 BOTTLE (47781-488-77)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 59651034701

NDC 959651-347
NDC 1059651-347-01
NDC Item59651034701
Packaging100 CAPSULE in 1 BOTTLE (59651-347-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034707

NDC 959651-347
NDC 1059651-347-07
NDC Item59651034707
Packaging1 BLISTER PACK in 1 CARTON (59651-347-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034721

NDC 959651-347
NDC 1059651-347-21
NDC Item59651034721
Packaging21 CAPSULE in 1 BOTTLE (59651-347-21)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453701

NDC 960505-4537
NDC 1060505-4537-1
NDC Item60505453701
Packaging100 CAPSULE in 1 BOTTLE (60505-4537-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 60505453702

NDC 960505-4537
NDC 1060505-4537-2
NDC Item60505453702
Packaging21 CAPSULE in 1 BOTTLE (60505-4537-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 63304004601

NDC 963304-046
NDC 1063304-046-01
NDC Item63304004601
Packaging100 CAPSULE in 1 BOTTLE (63304-046-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004622

NDC 963304-046
NDC 1063304-046-22
NDC Item63304004622
Packaging21 CAPSULE in 1 BOTTLE (63304-046-22)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038581

NDC 969097-385
NDC 1069097-385-81
NDC Item69097038581
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-385-81)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla25mg;385
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 70710103501

NDC 970710-1035
NDC 1070710-1035-1
NDC Item70710103501
Packaging100 CAPSULE in 1 BOTTLE (70710-1035-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70710103508

NDC 970710-1035
NDC 1070710-1035-8
NDC Item70710103508
Packaging21 CAPSULE in 1 BOTTLE (70710-1035-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168101

NDC 970771-1681
NDC 1070771-1681-1
NDC Item70771168101
Packaging100 CAPSULE in 1 BOTTLE (70771-1681-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168108

NDC 970771-1681
NDC 1070771-1681-8
NDC Item70771168108
Packaging21 CAPSULE in 1 BOTTLE (70771-1681-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 76282070147

NDC 976282-701
NDC 1076282-701-47
NDC Item76282070147
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-701-47)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id655779
Imprint codeCipla25mg;385
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194001

NDC 90378-1940
NDC 100378-1940-01
NDC Item00378194001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194021

NDC 90378-1940
NDC 100378-1940-21
NDC Item00378194021
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124621

NDC 90480-1246
NDC 100480-1246-21
NDC Item00480124621
Packaging21 CAPSULE in 1 BOTTLE (0480-1246-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;25mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-03-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722026201

NDC 931722-262
NDC 1031722-262-01
NDC Item31722026201
Packaging100 CAPSULE in 1 BOTTLE (31722-262-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026221

NDC 931722-262
NDC 1031722-262-21
NDC Item31722026221
Packaging21 CAPSULE in 1 BOTTLE (31722-262-21)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051501

NDC 943598-515
NDC 1043598-515-01
NDC Item43598051501
Packaging100 CAPSULE in 1 BOTTLE (43598-515-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 43598051521

NDC 943598-515
NDC 1043598-515-21
NDC Item43598051521
Packaging21 CAPSULE in 1 BOTTLE (43598-515-21)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 47781048801

NDC 947781-488
NDC 1047781-488-01
NDC Item47781048801
Packaging100 CAPSULE in 1 BOTTLE (47781-488-01)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 47781048877

NDC 947781-488
NDC 1047781-488-77
NDC Item47781048877
Packaging21 CAPSULE in 1 BOTTLE (47781-488-77)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 59651034701

NDC 959651-347
NDC 1059651-347-01
NDC Item59651034701
Packaging100 CAPSULE in 1 BOTTLE (59651-347-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034707

NDC 959651-347
NDC 1059651-347-07
NDC Item59651034707
Packaging1 BLISTER PACK in 1 CARTON (59651-347-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034721

NDC 959651-347
NDC 1059651-347-21
NDC Item59651034721
Packaging21 CAPSULE in 1 BOTTLE (59651-347-21)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453701

NDC 960505-4537
NDC 1060505-4537-1
NDC Item60505453701
Packaging100 CAPSULE in 1 BOTTLE (60505-4537-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 60505453702

NDC 960505-4537
NDC 1060505-4537-2
NDC Item60505453702
Packaging21 CAPSULE in 1 BOTTLE (60505-4537-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 63304004601

NDC 963304-046
NDC 1063304-046-01
NDC Item63304004601
Packaging100 CAPSULE in 1 BOTTLE (63304-046-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004622

NDC 963304-046
NDC 1063304-046-22
NDC Item63304004622
Packaging21 CAPSULE in 1 BOTTLE (63304-046-22)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038581

NDC 969097-385
NDC 1069097-385-81
NDC Item69097038581
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-385-81)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla25mg;385
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 70710103501

NDC 970710-1035
NDC 1070710-1035-1
NDC Item70710103501
Packaging100 CAPSULE in 1 BOTTLE (70710-1035-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70710103508

NDC 970710-1035
NDC 1070710-1035-8
NDC Item70710103508
Packaging21 CAPSULE in 1 BOTTLE (70710-1035-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168101

NDC 970771-1681
NDC 1070771-1681-1
NDC Item70771168101
Packaging100 CAPSULE in 1 BOTTLE (70771-1681-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168108

NDC 970771-1681
NDC 1070771-1681-8
NDC Item70771168108
Packaging21 CAPSULE in 1 BOTTLE (70771-1681-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 76282070147

NDC 976282-701
NDC 1076282-701-47
NDC Item76282070147
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-701-47)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id655779
Imprint codeCipla25mg;385
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194001

NDC 90378-1940
NDC 100378-1940-01
NDC Item00378194001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194021

NDC 90378-1940
NDC 100378-1940-21
NDC Item00378194021
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124621

NDC 90480-1246
NDC 100480-1246-21
NDC Item00480124621
Packaging21 CAPSULE in 1 BOTTLE (0480-1246-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;25mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-03-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722026201

NDC 931722-262
NDC 1031722-262-01
NDC Item31722026201
Packaging100 CAPSULE in 1 BOTTLE (31722-262-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026221

NDC 931722-262
NDC 1031722-262-21
NDC Item31722026221
Packaging21 CAPSULE in 1 BOTTLE (31722-262-21)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051501

NDC 943598-515
NDC 1043598-515-01
NDC Item43598051501
Packaging100 CAPSULE in 1 BOTTLE (43598-515-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 43598051521

NDC 943598-515
NDC 1043598-515-21
NDC Item43598051521
Packaging21 CAPSULE in 1 BOTTLE (43598-515-21)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 47781048801

NDC 947781-488
NDC 1047781-488-01
NDC Item47781048801
Packaging100 CAPSULE in 1 BOTTLE (47781-488-01)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 47781048877

NDC 947781-488
NDC 1047781-488-77
NDC Item47781048877
Packaging21 CAPSULE in 1 BOTTLE (47781-488-77)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 59651034701

NDC 959651-347
NDC 1059651-347-01
NDC Item59651034701
Packaging100 CAPSULE in 1 BOTTLE (59651-347-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034707

NDC 959651-347
NDC 1059651-347-07
NDC Item59651034707
Packaging1 BLISTER PACK in 1 CARTON (59651-347-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034721

NDC 959651-347
NDC 1059651-347-21
NDC Item59651034721
Packaging21 CAPSULE in 1 BOTTLE (59651-347-21)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453701

NDC 960505-4537
NDC 1060505-4537-1
NDC Item60505453701
Packaging100 CAPSULE in 1 BOTTLE (60505-4537-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 60505453702

NDC 960505-4537
NDC 1060505-4537-2
NDC Item60505453702
Packaging21 CAPSULE in 1 BOTTLE (60505-4537-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 63304004601

NDC 963304-046
NDC 1063304-046-01
NDC Item63304004601
Packaging100 CAPSULE in 1 BOTTLE (63304-046-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004622

NDC 963304-046
NDC 1063304-046-22
NDC Item63304004622
Packaging21 CAPSULE in 1 BOTTLE (63304-046-22)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038581

NDC 969097-385
NDC 1069097-385-81
NDC Item69097038581
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-385-81)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla25mg;385
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 70710103501

NDC 970710-1035
NDC 1070710-1035-1
NDC Item70710103501
Packaging100 CAPSULE in 1 BOTTLE (70710-1035-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70710103508

NDC 970710-1035
NDC 1070710-1035-8
NDC Item70710103508
Packaging21 CAPSULE in 1 BOTTLE (70710-1035-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168101

NDC 970771-1681
NDC 1070771-1681-1
NDC Item70771168101
Packaging100 CAPSULE in 1 BOTTLE (70771-1681-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168108

NDC 970771-1681
NDC 1070771-1681-8
NDC Item70771168108
Packaging21 CAPSULE in 1 BOTTLE (70771-1681-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 76282070147

NDC 976282-701
NDC 1076282-701-47
NDC Item76282070147
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-701-47)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id655779
Imprint codeCipla25mg;385
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194001

NDC 90378-1940
NDC 100378-1940-01
NDC Item00378194001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194021

NDC 90378-1940
NDC 100378-1940-21
NDC Item00378194021
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124621

NDC 90480-1246
NDC 100480-1246-21
NDC Item00480124621
Packaging21 CAPSULE in 1 BOTTLE (0480-1246-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;25mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-03-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722026201

NDC 931722-262
NDC 1031722-262-01
NDC Item31722026201
Packaging100 CAPSULE in 1 BOTTLE (31722-262-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026221

NDC 931722-262
NDC 1031722-262-21
NDC Item31722026221
Packaging21 CAPSULE in 1 BOTTLE (31722-262-21)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051501

NDC 943598-515
NDC 1043598-515-01
NDC Item43598051501
Packaging100 CAPSULE in 1 BOTTLE (43598-515-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 43598051521

NDC 943598-515
NDC 1043598-515-21
NDC Item43598051521
Packaging21 CAPSULE in 1 BOTTLE (43598-515-21)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 47781048801

NDC 947781-488
NDC 1047781-488-01
NDC Item47781048801
Packaging100 CAPSULE in 1 BOTTLE (47781-488-01)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 47781048877

NDC 947781-488
NDC 1047781-488-77
NDC Item47781048877
Packaging21 CAPSULE in 1 BOTTLE (47781-488-77)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 59651034701

NDC 959651-347
NDC 1059651-347-01
NDC Item59651034701
Packaging100 CAPSULE in 1 BOTTLE (59651-347-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034707

NDC 959651-347
NDC 1059651-347-07
NDC Item59651034707
Packaging1 BLISTER PACK in 1 CARTON (59651-347-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034721

NDC 959651-347
NDC 1059651-347-21
NDC Item59651034721
Packaging21 CAPSULE in 1 BOTTLE (59651-347-21)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453701

NDC 960505-4537
NDC 1060505-4537-1
NDC Item60505453701
Packaging100 CAPSULE in 1 BOTTLE (60505-4537-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 60505453702

NDC 960505-4537
NDC 1060505-4537-2
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Packaging21 CAPSULE in 1 BOTTLE (60505-4537-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 63304004601

NDC 963304-046
NDC 1063304-046-01
NDC Item63304004601
Packaging100 CAPSULE in 1 BOTTLE (63304-046-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004622

NDC 963304-046
NDC 1063304-046-22
NDC Item63304004622
Packaging21 CAPSULE in 1 BOTTLE (63304-046-22)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038581

NDC 969097-385
NDC 1069097-385-81
NDC Item69097038581
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-385-81)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla25mg;385
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 70710103501

NDC 970710-1035
NDC 1070710-1035-1
NDC Item70710103501
Packaging100 CAPSULE in 1 BOTTLE (70710-1035-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70710103508

NDC 970710-1035
NDC 1070710-1035-8
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Packaging21 CAPSULE in 1 BOTTLE (70710-1035-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168101

NDC 970771-1681
NDC 1070771-1681-1
NDC Item70771168101
Packaging100 CAPSULE in 1 BOTTLE (70771-1681-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168108

NDC 970771-1681
NDC 1070771-1681-8
NDC Item70771168108
Packaging21 CAPSULE in 1 BOTTLE (70771-1681-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 76282070147

NDC 976282-701
NDC 1076282-701-47
NDC Item76282070147
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-701-47)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id655779
Imprint codeCipla25mg;385
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194001

NDC 90378-1940
NDC 100378-1940-01
NDC Item00378194001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194021

NDC 90378-1940
NDC 100378-1940-21
NDC Item00378194021
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124621

NDC 90480-1246
NDC 100480-1246-21
NDC Item00480124621
Packaging21 CAPSULE in 1 BOTTLE (0480-1246-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;25mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-03-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722026201

NDC 931722-262
NDC 1031722-262-01
NDC Item31722026201
Packaging100 CAPSULE in 1 BOTTLE (31722-262-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026221

NDC 931722-262
NDC 1031722-262-21
NDC Item31722026221
Packaging21 CAPSULE in 1 BOTTLE (31722-262-21)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051501

NDC 943598-515
NDC 1043598-515-01
NDC Item43598051501
Packaging100 CAPSULE in 1 BOTTLE (43598-515-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 43598051521

NDC 943598-515
NDC 1043598-515-21
NDC Item43598051521
Packaging21 CAPSULE in 1 BOTTLE (43598-515-21)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 47781048801

NDC 947781-488
NDC 1047781-488-01
NDC Item47781048801
Packaging100 CAPSULE in 1 BOTTLE (47781-488-01)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 47781048877

NDC 947781-488
NDC 1047781-488-77
NDC Item47781048877
Packaging21 CAPSULE in 1 BOTTLE (47781-488-77)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 59651034701

NDC 959651-347
NDC 1059651-347-01
NDC Item59651034701
Packaging100 CAPSULE in 1 BOTTLE (59651-347-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034707

NDC 959651-347
NDC 1059651-347-07
NDC Item59651034707
Packaging1 BLISTER PACK in 1 CARTON (59651-347-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034721

NDC 959651-347
NDC 1059651-347-21
NDC Item59651034721
Packaging21 CAPSULE in 1 BOTTLE (59651-347-21)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453701

NDC 960505-4537
NDC 1060505-4537-1
NDC Item60505453701
Packaging100 CAPSULE in 1 BOTTLE (60505-4537-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 60505453702

NDC 960505-4537
NDC 1060505-4537-2
NDC Item60505453702
Packaging21 CAPSULE in 1 BOTTLE (60505-4537-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 63304004601

NDC 963304-046
NDC 1063304-046-01
NDC Item63304004601
Packaging100 CAPSULE in 1 BOTTLE (63304-046-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004622

NDC 963304-046
NDC 1063304-046-22
NDC Item63304004622
Packaging21 CAPSULE in 1 BOTTLE (63304-046-22)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038581

NDC 969097-385
NDC 1069097-385-81
NDC Item69097038581
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-385-81)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla25mg;385
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 70710103501

NDC 970710-1035
NDC 1070710-1035-1
NDC Item70710103501
Packaging100 CAPSULE in 1 BOTTLE (70710-1035-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70710103508

NDC 970710-1035
NDC 1070710-1035-8
NDC Item70710103508
Packaging21 CAPSULE in 1 BOTTLE (70710-1035-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168101

NDC 970771-1681
NDC 1070771-1681-1
NDC Item70771168101
Packaging100 CAPSULE in 1 BOTTLE (70771-1681-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168108

NDC 970771-1681
NDC 1070771-1681-8
NDC Item70771168108
Packaging21 CAPSULE in 1 BOTTLE (70771-1681-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 76282070147

NDC 976282-701
NDC 1076282-701-47
NDC Item76282070147
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-701-47)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id655779
Imprint codeCipla25mg;385
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194001

NDC 90378-1940
NDC 100378-1940-01
NDC Item00378194001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194021

NDC 90378-1940
NDC 100378-1940-21
NDC Item00378194021
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124621

NDC 90480-1246
NDC 100480-1246-21
NDC Item00480124621
Packaging21 CAPSULE in 1 BOTTLE (0480-1246-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;25mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-03-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722026201

NDC 931722-262
NDC 1031722-262-01
NDC Item31722026201
Packaging100 CAPSULE in 1 BOTTLE (31722-262-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026221

NDC 931722-262
NDC 1031722-262-21
NDC Item31722026221
Packaging21 CAPSULE in 1 BOTTLE (31722-262-21)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051501

NDC 943598-515
NDC 1043598-515-01
NDC Item43598051501
Packaging100 CAPSULE in 1 BOTTLE (43598-515-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 43598051521

NDC 943598-515
NDC 1043598-515-21
NDC Item43598051521
Packaging21 CAPSULE in 1 BOTTLE (43598-515-21)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 47781048801

NDC 947781-488
NDC 1047781-488-01
NDC Item47781048801
Packaging100 CAPSULE in 1 BOTTLE (47781-488-01)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 47781048877

NDC 947781-488
NDC 1047781-488-77
NDC Item47781048877
Packaging21 CAPSULE in 1 BOTTLE (47781-488-77)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 59651034701

NDC 959651-347
NDC 1059651-347-01
NDC Item59651034701
Packaging100 CAPSULE in 1 BOTTLE (59651-347-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034707

NDC 959651-347
NDC 1059651-347-07
NDC Item59651034707
Packaging1 BLISTER PACK in 1 CARTON (59651-347-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034721

NDC 959651-347
NDC 1059651-347-21
NDC Item59651034721
Packaging21 CAPSULE in 1 BOTTLE (59651-347-21)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453701

NDC 960505-4537
NDC 1060505-4537-1
NDC Item60505453701
Packaging100 CAPSULE in 1 BOTTLE (60505-4537-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 60505453702

NDC 960505-4537
NDC 1060505-4537-2
NDC Item60505453702
Packaging21 CAPSULE in 1 BOTTLE (60505-4537-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 63304004601

NDC 963304-046
NDC 1063304-046-01
NDC Item63304004601
Packaging100 CAPSULE in 1 BOTTLE (63304-046-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004622

NDC 963304-046
NDC 1063304-046-22
NDC Item63304004622
Packaging21 CAPSULE in 1 BOTTLE (63304-046-22)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038581

NDC 969097-385
NDC 1069097-385-81
NDC Item69097038581
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-385-81)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla25mg;385
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 70710103501

NDC 970710-1035
NDC 1070710-1035-1
NDC Item70710103501
Packaging100 CAPSULE in 1 BOTTLE (70710-1035-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70710103508

NDC 970710-1035
NDC 1070710-1035-8
NDC Item70710103508
Packaging21 CAPSULE in 1 BOTTLE (70710-1035-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168101

NDC 970771-1681
NDC 1070771-1681-1
NDC Item70771168101
Packaging100 CAPSULE in 1 BOTTLE (70771-1681-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168108

NDC 970771-1681
NDC 1070771-1681-8
NDC Item70771168108
Packaging21 CAPSULE in 1 BOTTLE (70771-1681-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 76282070147

NDC 976282-701
NDC 1076282-701-47
NDC Item76282070147
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-701-47)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id655779
Imprint codeCipla25mg;385
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194001

NDC 90378-1940
NDC 100378-1940-01
NDC Item00378194001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194021

NDC 90378-1940
NDC 100378-1940-21
NDC Item00378194021
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124621

NDC 90480-1246
NDC 100480-1246-21
NDC Item00480124621
Packaging21 CAPSULE in 1 BOTTLE (0480-1246-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;25mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-03-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722026201

NDC 931722-262
NDC 1031722-262-01
NDC Item31722026201
Packaging100 CAPSULE in 1 BOTTLE (31722-262-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026221

NDC 931722-262
NDC 1031722-262-21
NDC Item31722026221
Packaging21 CAPSULE in 1 BOTTLE (31722-262-21)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051501

NDC 943598-515
NDC 1043598-515-01
NDC Item43598051501
Packaging100 CAPSULE in 1 BOTTLE (43598-515-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 43598051521

NDC 943598-515
NDC 1043598-515-21
NDC Item43598051521
Packaging21 CAPSULE in 1 BOTTLE (43598-515-21)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 47781048801

NDC 947781-488
NDC 1047781-488-01
NDC Item47781048801
Packaging100 CAPSULE in 1 BOTTLE (47781-488-01)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 47781048877

NDC 947781-488
NDC 1047781-488-77
NDC Item47781048877
Packaging21 CAPSULE in 1 BOTTLE (47781-488-77)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 59651034701

NDC 959651-347
NDC 1059651-347-01
NDC Item59651034701
Packaging100 CAPSULE in 1 BOTTLE (59651-347-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034707

NDC 959651-347
NDC 1059651-347-07
NDC Item59651034707
Packaging1 BLISTER PACK in 1 CARTON (59651-347-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034721

NDC 959651-347
NDC 1059651-347-21
NDC Item59651034721
Packaging21 CAPSULE in 1 BOTTLE (59651-347-21)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453701

NDC 960505-4537
NDC 1060505-4537-1
NDC Item60505453701
Packaging100 CAPSULE in 1 BOTTLE (60505-4537-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 60505453702

NDC 960505-4537
NDC 1060505-4537-2
NDC Item60505453702
Packaging21 CAPSULE in 1 BOTTLE (60505-4537-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 63304004601

NDC 963304-046
NDC 1063304-046-01
NDC Item63304004601
Packaging100 CAPSULE in 1 BOTTLE (63304-046-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004622

NDC 963304-046
NDC 1063304-046-22
NDC Item63304004622
Packaging21 CAPSULE in 1 BOTTLE (63304-046-22)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038581

NDC 969097-385
NDC 1069097-385-81
NDC Item69097038581
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-385-81)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla25mg;385
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 70710103501

NDC 970710-1035
NDC 1070710-1035-1
NDC Item70710103501
Packaging100 CAPSULE in 1 BOTTLE (70710-1035-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70710103508

NDC 970710-1035
NDC 1070710-1035-8
NDC Item70710103508
Packaging21 CAPSULE in 1 BOTTLE (70710-1035-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168101

NDC 970771-1681
NDC 1070771-1681-1
NDC Item70771168101
Packaging100 CAPSULE in 1 BOTTLE (70771-1681-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168108

NDC 970771-1681
NDC 1070771-1681-8
NDC Item70771168108
Packaging21 CAPSULE in 1 BOTTLE (70771-1681-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 76282070147

NDC 976282-701
NDC 1076282-701-47
NDC Item76282070147
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-701-47)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id655779
Imprint codeCipla25mg;385
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194001

NDC 90378-1940
NDC 100378-1940-01
NDC Item00378194001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194021

NDC 90378-1940
NDC 100378-1940-21
NDC Item00378194021
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124621

NDC 90480-1246
NDC 100480-1246-21
NDC Item00480124621
Packaging21 CAPSULE in 1 BOTTLE (0480-1246-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;25mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-03-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722026201

NDC 931722-262
NDC 1031722-262-01
NDC Item31722026201
Packaging100 CAPSULE in 1 BOTTLE (31722-262-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026221

NDC 931722-262
NDC 1031722-262-21
NDC Item31722026221
Packaging21 CAPSULE in 1 BOTTLE (31722-262-21)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051501

NDC 943598-515
NDC 1043598-515-01
NDC Item43598051501
Packaging100 CAPSULE in 1 BOTTLE (43598-515-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 43598051521

NDC 943598-515
NDC 1043598-515-21
NDC Item43598051521
Packaging21 CAPSULE in 1 BOTTLE (43598-515-21)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 47781048801

NDC 947781-488
NDC 1047781-488-01
NDC Item47781048801
Packaging100 CAPSULE in 1 BOTTLE (47781-488-01)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 47781048877

NDC 947781-488
NDC 1047781-488-77
NDC Item47781048877
Packaging21 CAPSULE in 1 BOTTLE (47781-488-77)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 59651034701

NDC 959651-347
NDC 1059651-347-01
NDC Item59651034701
Packaging100 CAPSULE in 1 BOTTLE (59651-347-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034707

NDC 959651-347
NDC 1059651-347-07
NDC Item59651034707
Packaging1 BLISTER PACK in 1 CARTON (59651-347-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034721

NDC 959651-347
NDC 1059651-347-21
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Packaging21 CAPSULE in 1 BOTTLE (59651-347-21)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453701

NDC 960505-4537
NDC 1060505-4537-1
NDC Item60505453701
Packaging100 CAPSULE in 1 BOTTLE (60505-4537-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 60505453702

NDC 960505-4537
NDC 1060505-4537-2
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Packaging21 CAPSULE in 1 BOTTLE (60505-4537-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 63304004601

NDC 963304-046
NDC 1063304-046-01
NDC Item63304004601
Packaging100 CAPSULE in 1 BOTTLE (63304-046-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004622

NDC 963304-046
NDC 1063304-046-22
NDC Item63304004622
Packaging21 CAPSULE in 1 BOTTLE (63304-046-22)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038581

NDC 969097-385
NDC 1069097-385-81
NDC Item69097038581
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-385-81)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla25mg;385
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 70710103501

NDC 970710-1035
NDC 1070710-1035-1
NDC Item70710103501
Packaging100 CAPSULE in 1 BOTTLE (70710-1035-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70710103508

NDC 970710-1035
NDC 1070710-1035-8
NDC Item70710103508
Packaging21 CAPSULE in 1 BOTTLE (70710-1035-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168101

NDC 970771-1681
NDC 1070771-1681-1
NDC Item70771168101
Packaging100 CAPSULE in 1 BOTTLE (70771-1681-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168108

NDC 970771-1681
NDC 1070771-1681-8
NDC Item70771168108
Packaging21 CAPSULE in 1 BOTTLE (70771-1681-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 76282070147

NDC 976282-701
NDC 1076282-701-47
NDC Item76282070147
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-701-47)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id655779
Imprint codeCipla25mg;385
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194001

NDC 90378-1940
NDC 100378-1940-01
NDC Item00378194001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194021

NDC 90378-1940
NDC 100378-1940-21
NDC Item00378194021
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124621

NDC 90480-1246
NDC 100480-1246-21
NDC Item00480124621
Packaging21 CAPSULE in 1 BOTTLE (0480-1246-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;25mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-03-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722026201

NDC 931722-262
NDC 1031722-262-01
NDC Item31722026201
Packaging100 CAPSULE in 1 BOTTLE (31722-262-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026221

NDC 931722-262
NDC 1031722-262-21
NDC Item31722026221
Packaging21 CAPSULE in 1 BOTTLE (31722-262-21)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051501

NDC 943598-515
NDC 1043598-515-01
NDC Item43598051501
Packaging100 CAPSULE in 1 BOTTLE (43598-515-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 43598051521

NDC 943598-515
NDC 1043598-515-21
NDC Item43598051521
Packaging21 CAPSULE in 1 BOTTLE (43598-515-21)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 47781048801

NDC 947781-488
NDC 1047781-488-01
NDC Item47781048801
Packaging100 CAPSULE in 1 BOTTLE (47781-488-01)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 47781048877

NDC 947781-488
NDC 1047781-488-77
NDC Item47781048877
Packaging21 CAPSULE in 1 BOTTLE (47781-488-77)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 59651034701

NDC 959651-347
NDC 1059651-347-01
NDC Item59651034701
Packaging100 CAPSULE in 1 BOTTLE (59651-347-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034707

NDC 959651-347
NDC 1059651-347-07
NDC Item59651034707
Packaging1 BLISTER PACK in 1 CARTON (59651-347-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034721

NDC 959651-347
NDC 1059651-347-21
NDC Item59651034721
Packaging21 CAPSULE in 1 BOTTLE (59651-347-21)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453701

NDC 960505-4537
NDC 1060505-4537-1
NDC Item60505453701
Packaging100 CAPSULE in 1 BOTTLE (60505-4537-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 60505453702

NDC 960505-4537
NDC 1060505-4537-2
NDC Item60505453702
Packaging21 CAPSULE in 1 BOTTLE (60505-4537-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 63304004601

NDC 963304-046
NDC 1063304-046-01
NDC Item63304004601
Packaging100 CAPSULE in 1 BOTTLE (63304-046-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004622

NDC 963304-046
NDC 1063304-046-22
NDC Item63304004622
Packaging21 CAPSULE in 1 BOTTLE (63304-046-22)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038581

NDC 969097-385
NDC 1069097-385-81
NDC Item69097038581
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-385-81)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla25mg;385
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 70710103501

NDC 970710-1035
NDC 1070710-1035-1
NDC Item70710103501
Packaging100 CAPSULE in 1 BOTTLE (70710-1035-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70710103508

NDC 970710-1035
NDC 1070710-1035-8
NDC Item70710103508
Packaging21 CAPSULE in 1 BOTTLE (70710-1035-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168101

NDC 970771-1681
NDC 1070771-1681-1
NDC Item70771168101
Packaging100 CAPSULE in 1 BOTTLE (70771-1681-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168108

NDC 970771-1681
NDC 1070771-1681-8
NDC Item70771168108
Packaging21 CAPSULE in 1 BOTTLE (70771-1681-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 76282070147

NDC 976282-701
NDC 1076282-701-47
NDC Item76282070147
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-701-47)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id655779
Imprint codeCipla25mg;385
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194001

NDC 90378-1940
NDC 100378-1940-01
NDC Item00378194001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194021

NDC 90378-1940
NDC 100378-1940-21
NDC Item00378194021
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124621

NDC 90480-1246
NDC 100480-1246-21
NDC Item00480124621
Packaging21 CAPSULE in 1 BOTTLE (0480-1246-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;25mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-03-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722026201

NDC 931722-262
NDC 1031722-262-01
NDC Item31722026201
Packaging100 CAPSULE in 1 BOTTLE (31722-262-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026221

NDC 931722-262
NDC 1031722-262-21
NDC Item31722026221
Packaging21 CAPSULE in 1 BOTTLE (31722-262-21)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051501

NDC 943598-515
NDC 1043598-515-01
NDC Item43598051501
Packaging100 CAPSULE in 1 BOTTLE (43598-515-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 43598051521

NDC 943598-515
NDC 1043598-515-21
NDC Item43598051521
Packaging21 CAPSULE in 1 BOTTLE (43598-515-21)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 47781048801

NDC 947781-488
NDC 1047781-488-01
NDC Item47781048801
Packaging100 CAPSULE in 1 BOTTLE (47781-488-01)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 47781048877

NDC 947781-488
NDC 1047781-488-77
NDC Item47781048877
Packaging21 CAPSULE in 1 BOTTLE (47781-488-77)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 59651034701

NDC 959651-347
NDC 1059651-347-01
NDC Item59651034701
Packaging100 CAPSULE in 1 BOTTLE (59651-347-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034707

NDC 959651-347
NDC 1059651-347-07
NDC Item59651034707
Packaging1 BLISTER PACK in 1 CARTON (59651-347-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034721

NDC 959651-347
NDC 1059651-347-21
NDC Item59651034721
Packaging21 CAPSULE in 1 BOTTLE (59651-347-21)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453701

NDC 960505-4537
NDC 1060505-4537-1
NDC Item60505453701
Packaging100 CAPSULE in 1 BOTTLE (60505-4537-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 60505453702

NDC 960505-4537
NDC 1060505-4537-2
NDC Item60505453702
Packaging21 CAPSULE in 1 BOTTLE (60505-4537-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 63304004601

NDC 963304-046
NDC 1063304-046-01
NDC Item63304004601
Packaging100 CAPSULE in 1 BOTTLE (63304-046-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004622

NDC 963304-046
NDC 1063304-046-22
NDC Item63304004622
Packaging21 CAPSULE in 1 BOTTLE (63304-046-22)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038581

NDC 969097-385
NDC 1069097-385-81
NDC Item69097038581
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-385-81)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla25mg;385
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 70710103501

NDC 970710-1035
NDC 1070710-1035-1
NDC Item70710103501
Packaging100 CAPSULE in 1 BOTTLE (70710-1035-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70710103508

NDC 970710-1035
NDC 1070710-1035-8
NDC Item70710103508
Packaging21 CAPSULE in 1 BOTTLE (70710-1035-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168101

NDC 970771-1681
NDC 1070771-1681-1
NDC Item70771168101
Packaging100 CAPSULE in 1 BOTTLE (70771-1681-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168108

NDC 970771-1681
NDC 1070771-1681-8
NDC Item70771168108
Packaging21 CAPSULE in 1 BOTTLE (70771-1681-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 76282070147

NDC 976282-701
NDC 1076282-701-47
NDC Item76282070147
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-701-47)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id655779
Imprint codeCipla25mg;385
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194001

NDC 90378-1940
NDC 100378-1940-01
NDC Item00378194001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194021

NDC 90378-1940
NDC 100378-1940-21
NDC Item00378194021
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124621

NDC 90480-1246
NDC 100480-1246-21
NDC Item00480124621
Packaging21 CAPSULE in 1 BOTTLE (0480-1246-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;25mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-03-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722026201

NDC 931722-262
NDC 1031722-262-01
NDC Item31722026201
Packaging100 CAPSULE in 1 BOTTLE (31722-262-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026221

NDC 931722-262
NDC 1031722-262-21
NDC Item31722026221
Packaging21 CAPSULE in 1 BOTTLE (31722-262-21)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051501

NDC 943598-515
NDC 1043598-515-01
NDC Item43598051501
Packaging100 CAPSULE in 1 BOTTLE (43598-515-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 43598051521

NDC 943598-515
NDC 1043598-515-21
NDC Item43598051521
Packaging21 CAPSULE in 1 BOTTLE (43598-515-21)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 47781048801

NDC 947781-488
NDC 1047781-488-01
NDC Item47781048801
Packaging100 CAPSULE in 1 BOTTLE (47781-488-01)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 47781048877

NDC 947781-488
NDC 1047781-488-77
NDC Item47781048877
Packaging21 CAPSULE in 1 BOTTLE (47781-488-77)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 59651034701

NDC 959651-347
NDC 1059651-347-01
NDC Item59651034701
Packaging100 CAPSULE in 1 BOTTLE (59651-347-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034707

NDC 959651-347
NDC 1059651-347-07
NDC Item59651034707
Packaging1 BLISTER PACK in 1 CARTON (59651-347-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034721

NDC 959651-347
NDC 1059651-347-21
NDC Item59651034721
Packaging21 CAPSULE in 1 BOTTLE (59651-347-21)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453701

NDC 960505-4537
NDC 1060505-4537-1
NDC Item60505453701
Packaging100 CAPSULE in 1 BOTTLE (60505-4537-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 60505453702

NDC 960505-4537
NDC 1060505-4537-2
NDC Item60505453702
Packaging21 CAPSULE in 1 BOTTLE (60505-4537-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 63304004601

NDC 963304-046
NDC 1063304-046-01
NDC Item63304004601
Packaging100 CAPSULE in 1 BOTTLE (63304-046-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004622

NDC 963304-046
NDC 1063304-046-22
NDC Item63304004622
Packaging21 CAPSULE in 1 BOTTLE (63304-046-22)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038581

NDC 969097-385
NDC 1069097-385-81
NDC Item69097038581
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-385-81)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla25mg;385
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 70710103501

NDC 970710-1035
NDC 1070710-1035-1
NDC Item70710103501
Packaging100 CAPSULE in 1 BOTTLE (70710-1035-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70710103508

NDC 970710-1035
NDC 1070710-1035-8
NDC Item70710103508
Packaging21 CAPSULE in 1 BOTTLE (70710-1035-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168101

NDC 970771-1681
NDC 1070771-1681-1
NDC Item70771168101
Packaging100 CAPSULE in 1 BOTTLE (70771-1681-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168108

NDC 970771-1681
NDC 1070771-1681-8
NDC Item70771168108
Packaging21 CAPSULE in 1 BOTTLE (70771-1681-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 76282070147

NDC 976282-701
NDC 1076282-701-47
NDC Item76282070147
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-701-47)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id655779
Imprint codeCipla25mg;385
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194001

NDC 90378-1940
NDC 100378-1940-01
NDC Item00378194001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194021

NDC 90378-1940
NDC 100378-1940-21
NDC Item00378194021
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124621

NDC 90480-1246
NDC 100480-1246-21
NDC Item00480124621
Packaging21 CAPSULE in 1 BOTTLE (0480-1246-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;25mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-03-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722026201

NDC 931722-262
NDC 1031722-262-01
NDC Item31722026201
Packaging100 CAPSULE in 1 BOTTLE (31722-262-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026221

NDC 931722-262
NDC 1031722-262-21
NDC Item31722026221
Packaging21 CAPSULE in 1 BOTTLE (31722-262-21)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051501

NDC 943598-515
NDC 1043598-515-01
NDC Item43598051501
Packaging100 CAPSULE in 1 BOTTLE (43598-515-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 43598051521

NDC 943598-515
NDC 1043598-515-21
NDC Item43598051521
Packaging21 CAPSULE in 1 BOTTLE (43598-515-21)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 47781048801

NDC 947781-488
NDC 1047781-488-01
NDC Item47781048801
Packaging100 CAPSULE in 1 BOTTLE (47781-488-01)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 47781048877

NDC 947781-488
NDC 1047781-488-77
NDC Item47781048877
Packaging21 CAPSULE in 1 BOTTLE (47781-488-77)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 59651034701

NDC 959651-347
NDC 1059651-347-01
NDC Item59651034701
Packaging100 CAPSULE in 1 BOTTLE (59651-347-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034707

NDC 959651-347
NDC 1059651-347-07
NDC Item59651034707
Packaging1 BLISTER PACK in 1 CARTON (59651-347-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034721

NDC 959651-347
NDC 1059651-347-21
NDC Item59651034721
Packaging21 CAPSULE in 1 BOTTLE (59651-347-21)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453701

NDC 960505-4537
NDC 1060505-4537-1
NDC Item60505453701
Packaging100 CAPSULE in 1 BOTTLE (60505-4537-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 60505453702

NDC 960505-4537
NDC 1060505-4537-2
NDC Item60505453702
Packaging21 CAPSULE in 1 BOTTLE (60505-4537-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 63304004601

NDC 963304-046
NDC 1063304-046-01
NDC Item63304004601
Packaging100 CAPSULE in 1 BOTTLE (63304-046-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004622

NDC 963304-046
NDC 1063304-046-22
NDC Item63304004622
Packaging21 CAPSULE in 1 BOTTLE (63304-046-22)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038581

NDC 969097-385
NDC 1069097-385-81
NDC Item69097038581
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-385-81)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla25mg;385
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 70710103501

NDC 970710-1035
NDC 1070710-1035-1
NDC Item70710103501
Packaging100 CAPSULE in 1 BOTTLE (70710-1035-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70710103508

NDC 970710-1035
NDC 1070710-1035-8
NDC Item70710103508
Packaging21 CAPSULE in 1 BOTTLE (70710-1035-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168101

NDC 970771-1681
NDC 1070771-1681-1
NDC Item70771168101
Packaging100 CAPSULE in 1 BOTTLE (70771-1681-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168108

NDC 970771-1681
NDC 1070771-1681-8
NDC Item70771168108
Packaging21 CAPSULE in 1 BOTTLE (70771-1681-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 76282070147

NDC 976282-701
NDC 1076282-701-47
NDC Item76282070147
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-701-47)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id655779
Imprint codeCipla25mg;385
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194001

NDC 90378-1940
NDC 100378-1940-01
NDC Item00378194001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194021

NDC 90378-1940
NDC 100378-1940-21
NDC Item00378194021
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124621

NDC 90480-1246
NDC 100480-1246-21
NDC Item00480124621
Packaging21 CAPSULE in 1 BOTTLE (0480-1246-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;25mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-03-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722026201

NDC 931722-262
NDC 1031722-262-01
NDC Item31722026201
Packaging100 CAPSULE in 1 BOTTLE (31722-262-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026221

NDC 931722-262
NDC 1031722-262-21
NDC Item31722026221
Packaging21 CAPSULE in 1 BOTTLE (31722-262-21)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051501

NDC 943598-515
NDC 1043598-515-01
NDC Item43598051501
Packaging100 CAPSULE in 1 BOTTLE (43598-515-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 43598051521

NDC 943598-515
NDC 1043598-515-21
NDC Item43598051521
Packaging21 CAPSULE in 1 BOTTLE (43598-515-21)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 47781048801

NDC 947781-488
NDC 1047781-488-01
NDC Item47781048801
Packaging100 CAPSULE in 1 BOTTLE (47781-488-01)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 47781048877

NDC 947781-488
NDC 1047781-488-77
NDC Item47781048877
Packaging21 CAPSULE in 1 BOTTLE (47781-488-77)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 59651034701

NDC 959651-347
NDC 1059651-347-01
NDC Item59651034701
Packaging100 CAPSULE in 1 BOTTLE (59651-347-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034707

NDC 959651-347
NDC 1059651-347-07
NDC Item59651034707
Packaging1 BLISTER PACK in 1 CARTON (59651-347-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034721

NDC 959651-347
NDC 1059651-347-21
NDC Item59651034721
Packaging21 CAPSULE in 1 BOTTLE (59651-347-21)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453701

NDC 960505-4537
NDC 1060505-4537-1
NDC Item60505453701
Packaging100 CAPSULE in 1 BOTTLE (60505-4537-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 60505453702

NDC 960505-4537
NDC 1060505-4537-2
NDC Item60505453702
Packaging21 CAPSULE in 1 BOTTLE (60505-4537-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 63304004601

NDC 963304-046
NDC 1063304-046-01
NDC Item63304004601
Packaging100 CAPSULE in 1 BOTTLE (63304-046-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004622

NDC 963304-046
NDC 1063304-046-22
NDC Item63304004622
Packaging21 CAPSULE in 1 BOTTLE (63304-046-22)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038581

NDC 969097-385
NDC 1069097-385-81
NDC Item69097038581
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-385-81)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla25mg;385
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 70710103501

NDC 970710-1035
NDC 1070710-1035-1
NDC Item70710103501
Packaging100 CAPSULE in 1 BOTTLE (70710-1035-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70710103508

NDC 970710-1035
NDC 1070710-1035-8
NDC Item70710103508
Packaging21 CAPSULE in 1 BOTTLE (70710-1035-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168101

NDC 970771-1681
NDC 1070771-1681-1
NDC Item70771168101
Packaging100 CAPSULE in 1 BOTTLE (70771-1681-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 70771168108

NDC 970771-1681
NDC 1070771-1681-8
NDC Item70771168108
Packaging21 CAPSULE in 1 BOTTLE (70771-1681-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
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NDC Item 76282070147

NDC 976282-701
NDC 1076282-701-47
NDC Item76282070147
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-701-47)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id655779
Imprint codeCipla25mg;385
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194001

NDC 90378-1940
NDC 100378-1940-01
NDC Item00378194001
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194021

NDC 90378-1940
NDC 100378-1940-21
NDC Item00378194021
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1940-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;25
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124621

NDC 90480-1246
NDC 100480-1246-21
NDC Item00480124621
Packaging21 CAPSULE in 1 BOTTLE (0480-1246-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;25mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-03-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722026201

NDC 931722-262
NDC 1031722-262-01
NDC Item31722026201
Packaging100 CAPSULE in 1 BOTTLE (31722-262-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 31722-262

NDC Item 31722026221

NDC 931722-262
NDC 1031722-262-21
NDC Item31722026221
Packaging21 CAPSULE in 1 BOTTLE (31722-262-21)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id718892
Imprint codeH;L7
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 31722-262

NDC Item 43598051501

NDC 943598-515
NDC 1043598-515-01
NDC Item43598051501
Packaging100 CAPSULE in 1 BOTTLE (43598-515-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 43598-515

NDC Item 43598051521

NDC 943598-515
NDC 1043598-515-21
NDC Item43598051521
Packaging21 CAPSULE in 1 BOTTLE (43598-515-21)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;25;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 43598-515

NDC Item 47781048801

NDC 947781-488
NDC 1047781-488-01
NDC Item47781048801
Packaging100 CAPSULE in 1 BOTTLE (47781-488-01)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 47781-488

NDC Item 47781048877

NDC 947781-488
NDC 1047781-488-77
NDC Item47781048877
Packaging21 CAPSULE in 1 BOTTLE (47781-488-77)
ANDAANDA210480
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id789803
Imprint codeLP;642
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 47781-488

NDC Item 59651034701

NDC 959651-347
NDC 1059651-347-01
NDC Item59651034701
Packaging100 CAPSULE in 1 BOTTLE (59651-347-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 59651-347

NDC Item 59651034707

NDC 959651-347
NDC 1059651-347-07
NDC Item59651034707
Packaging1 BLISTER PACK in 1 CARTON (59651-347-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 59651-347

NDC Item 59651034721

NDC 959651-347
NDC 1059651-347-21
NDC Item59651034721
Packaging21 CAPSULE in 1 BOTTLE (59651-347-21)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;25
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 59651-347

NDC Item 60505453701

NDC 960505-4537
NDC 1060505-4537-1
NDC Item60505453701
Packaging100 CAPSULE in 1 BOTTLE (60505-4537-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 60505-4537

NDC Item 60505453702

NDC 960505-4537
NDC 1060505-4537-2
NDC Item60505453702
Packaging21 CAPSULE in 1 BOTTLE (60505-4537-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),WHITE(White opaque)
ColorC48325;C48325 __
FDA SPL set id707296
Imprint codeAPO;L25
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 60505-4537

NDC Item 63304004601

NDC 963304-046
NDC 1063304-046-01
NDC Item63304004601
Packaging100 CAPSULE in 1 BOTTLE (63304-046-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 63304-046

NDC Item 63304004622

NDC 963304-046
NDC 1063304-046-22
NDC Item63304004622
Packaging21 CAPSULE in 1 BOTTLE (63304-046-22)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;83
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 63304-046

NDC Item 69097038581

NDC 969097-385
NDC 1069097-385-81
NDC Item69097038581
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-385-81)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla25mg;385
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 69097-385

NDC Item 70710103501

NDC 970710-1035
NDC 1070710-1035-1
NDC Item70710103501
Packaging100 CAPSULE in 1 BOTTLE (70710-1035-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 70710-1035

NDC Item 70710103508

NDC 970710-1035
NDC 1070710-1035-8
NDC Item70710103508
Packaging21 CAPSULE in 1 BOTTLE (70710-1035-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1035
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 70710-1035

NDC Item 70771168101

NDC 970771-1681
NDC 1070771-1681-1
NDC Item70771168101
Packaging100 CAPSULE in 1 BOTTLE (70771-1681-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 70771-1681

NDC Item 70771168108

NDC 970771-1681
NDC 1070771-1681-8
NDC Item70771168108
Packaging21 CAPSULE in 1 BOTTLE (70771-1681-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id731991
Imprint code1035
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 70771-1681

NDC Item 76282070147

NDC 976282-701
NDC 1076282-701-47
NDC Item76282070147
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-701-47)
ANDAANDA210435
COLORTEXTWHITE
ColorC48325 __
FDA SPL set id655779
Imprint codeCipla25mg;385
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 76282-701