RxSearch

NDC properties for "lenalidomide 5 MG Oral Capsule" (RxCUI 602912)

About this data

The tables show NDC propoerties for lenalidomide 5 MG Oral Capsule with the RxCUI 602912

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 5 MG Oral Capsule (RxCUI 602912)

ANDAANDA201452
ANDAANDA209348
ANDAANDA210154
ANDAANDA210435
ANDAANDA210480
ANDAANDA211022
ANDAANDA211846
ANDAANDA212414
ANDAANDA213885
ANDAANDA213912
MMSL_CODEBD15733
MMSL_CODECD15733
RxCUI602912
SNOMEDCT422330004
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
VUID4025035
Prescribable Synonymlenalidomide 5 MG Oral Capsule
RXNAV_STRlenalidomide 5 MG Oral Capsule
RxNorm Namelenalidomide 5 MG Oral Capsule
Related queriesInteractions (for RxCUI 602912)



NDC Properties

NDC Item 00378193601

NDC 90378-1936
NDC 100378-1936-01
NDC Item00378193601
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 0378-1936

NDC Item 00378193628

NDC 90378-1936
NDC 100378-1936-28
NDC Item00378193628
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-28)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 0378-1936

NDC Item 00480124228

NDC 90480-1242
NDC 100480-1242-28
NDC Item00480124228
Packaging28 CAPSULE in 1 BOTTLE (0480-1242-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;5mg
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 0480-1242

NDC Item 31722025801

NDC 931722-258
NDC 1031722-258-01
NDC Item31722025801
Packaging100 CAPSULE in 1 BOTTLE (31722-258-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 31722-258

NDC Item 31722025828

NDC 931722-258
NDC 1031722-258-28
NDC Item31722025828
Packaging28 CAPSULE in 1 BOTTLE (31722-258-28)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 31722-258

NDC Item 43598051101

NDC 943598-511
NDC 1043598-511-01
NDC Item43598051101
Packaging100 CAPSULE in 1 BOTTLE (43598-511-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43598-511

NDC Item 43598051163

NDC 943598-511
NDC 1043598-511-63
NDC Item43598051163
Packaging28 CAPSULE in 1 BOTTLE (43598-511-63)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43598-511

NDC Item 47781048401

NDC 947781-484
NDC 1047781-484-01
NDC Item47781048401
Packaging100 CAPSULE in 1 BOTTLE (47781-484-01)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 47781-484

NDC Item 47781048428

NDC 947781-484
NDC 1047781-484-28
NDC Item47781048428
Packaging28 CAPSULE in 1 BOTTLE (47781-484-28)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 47781-484

NDC Item 59651034301

NDC 959651-343
NDC 1059651-343-01
NDC Item59651034301
Packaging100 CAPSULE in 1 BOTTLE (59651-343-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 59651-343

NDC Item 59651034307

NDC 959651-343
NDC 1059651-343-07
NDC Item59651034307
Packaging1 BLISTER PACK in 1 CARTON (59651-343-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 59651-343

NDC Item 59651034328

NDC 959651-343
NDC 1059651-343-28
NDC Item59651034328
Packaging28 CAPSULE in 1 BOTTLE (59651-343-28)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 59651-343

NDC Item 60505453301

NDC 960505-4533
NDC 1060505-4533-1
NDC Item60505453301
Packaging100 CAPSULE in 1 BOTTLE (60505-4533-1)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 60505-4533

NDC Item 60505453302

NDC 960505-4533
NDC 1060505-4533-2
NDC Item60505453302
Packaging28 CAPSULE in 1 BOTTLE (60505-4533-2)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 60505-4533

NDC Item 63304004201

NDC 963304-042
NDC 1063304-042-01
NDC Item63304004201
Packaging100 CAPSULE in 1 BOTTLE (63304-042-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 63304-042

NDC Item 63304004227

NDC 963304-042
NDC 1063304-042-27
NDC Item63304004227
Packaging28 CAPSULE in 1 BOTTLE (63304-042-27)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 63304-042

NDC Item 69097038173

NDC 969097-381
NDC 1069097-381-73
NDC Item69097038173
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (69097-381-73)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla5mg;381
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 69097-381

NDC Item 70710103101

NDC 970710-1031
NDC 1070710-1031-1
NDC Item70710103101
Packaging100 CAPSULE in 1 BOTTLE (70710-1031-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
Related queriesProperties for NDC 9 70710-1031

NDC Item 70710103107

NDC 970710-1031
NDC 1070710-1031-7
NDC Item70710103107
Packaging28 CAPSULE in 1 BOTTLE (70710-1031-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
Related queriesProperties for NDC 9 70710-1031

NDC Item 70771167701

NDC 970771-1677
NDC 1070771-1677-1
NDC Item70771167701
Packaging100 CAPSULE in 1 BOTTLE (70771-1677-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
Related queriesProperties for NDC 9 70771-1677

NDC Item 70771167707

NDC 970771-1677
NDC 1070771-1677-7
NDC Item70771167707
Packaging28 CAPSULE in 1 BOTTLE (70771-1677-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
Related queriesProperties for NDC 9 70771-1677

NDC Item 76282069748

NDC 976282-697
NDC 1076282-697-48
NDC Item76282069748
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (76282-697-48)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id792852
Imprint codeCipla5mg;381
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 76282-697

NDC Item 00378193601

NDC 90378-1936
NDC 100378-1936-01
NDC Item00378193601
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 0378-1936

NDC Item 00378193628

NDC 90378-1936
NDC 100378-1936-28
NDC Item00378193628
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-28)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 0378-1936

NDC Item 00480124228

NDC 90480-1242
NDC 100480-1242-28
NDC Item00480124228
Packaging28 CAPSULE in 1 BOTTLE (0480-1242-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;5mg
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 0480-1242

NDC Item 31722025801

NDC 931722-258
NDC 1031722-258-01
NDC Item31722025801
Packaging100 CAPSULE in 1 BOTTLE (31722-258-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 31722-258

NDC Item 31722025828

NDC 931722-258
NDC 1031722-258-28
NDC Item31722025828
Packaging28 CAPSULE in 1 BOTTLE (31722-258-28)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 31722-258

NDC Item 43598051101

NDC 943598-511
NDC 1043598-511-01
NDC Item43598051101
Packaging100 CAPSULE in 1 BOTTLE (43598-511-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43598-511

NDC Item 43598051163

NDC 943598-511
NDC 1043598-511-63
NDC Item43598051163
Packaging28 CAPSULE in 1 BOTTLE (43598-511-63)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43598-511

NDC Item 47781048401

NDC 947781-484
NDC 1047781-484-01
NDC Item47781048401
Packaging100 CAPSULE in 1 BOTTLE (47781-484-01)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 47781-484

NDC Item 47781048428

NDC 947781-484
NDC 1047781-484-28
NDC Item47781048428
Packaging28 CAPSULE in 1 BOTTLE (47781-484-28)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 47781-484

NDC Item 59651034301

NDC 959651-343
NDC 1059651-343-01
NDC Item59651034301
Packaging100 CAPSULE in 1 BOTTLE (59651-343-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 59651-343

NDC Item 59651034307

NDC 959651-343
NDC 1059651-343-07
NDC Item59651034307
Packaging1 BLISTER PACK in 1 CARTON (59651-343-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 59651-343

NDC Item 59651034328

NDC 959651-343
NDC 1059651-343-28
NDC Item59651034328
Packaging28 CAPSULE in 1 BOTTLE (59651-343-28)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 59651-343

NDC Item 60505453301

NDC 960505-4533
NDC 1060505-4533-1
NDC Item60505453301
Packaging100 CAPSULE in 1 BOTTLE (60505-4533-1)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 60505-4533

NDC Item 60505453302

NDC 960505-4533
NDC 1060505-4533-2
NDC Item60505453302
Packaging28 CAPSULE in 1 BOTTLE (60505-4533-2)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 60505-4533

NDC Item 63304004201

NDC 963304-042
NDC 1063304-042-01
NDC Item63304004201
Packaging100 CAPSULE in 1 BOTTLE (63304-042-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 63304-042

NDC Item 63304004227

NDC 963304-042
NDC 1063304-042-27
NDC Item63304004227
Packaging28 CAPSULE in 1 BOTTLE (63304-042-27)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 63304-042

NDC Item 69097038173

NDC 969097-381
NDC 1069097-381-73
NDC Item69097038173
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (69097-381-73)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla5mg;381
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 69097-381

NDC Item 70710103101

NDC 970710-1031
NDC 1070710-1031-1
NDC Item70710103101
Packaging100 CAPSULE in 1 BOTTLE (70710-1031-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103107

NDC 970710-1031
NDC 1070710-1031-7
NDC Item70710103107
Packaging28 CAPSULE in 1 BOTTLE (70710-1031-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167701

NDC 970771-1677
NDC 1070771-1677-1
NDC Item70771167701
Packaging100 CAPSULE in 1 BOTTLE (70771-1677-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167707

NDC 970771-1677
NDC 1070771-1677-7
NDC Item70771167707
Packaging28 CAPSULE in 1 BOTTLE (70771-1677-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069748

NDC 976282-697
NDC 1076282-697-48
NDC Item76282069748
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (76282-697-48)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id792852
Imprint codeCipla5mg;381
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193601

NDC 90378-1936
NDC 100378-1936-01
NDC Item00378193601
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193628

NDC 90378-1936
NDC 100378-1936-28
NDC Item00378193628
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-28)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00480124228

NDC 90480-1242
NDC 100480-1242-28
NDC Item00480124228
Packaging28 CAPSULE in 1 BOTTLE (0480-1242-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;5mg
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 31722025801

NDC 931722-258
NDC 1031722-258-01
NDC Item31722025801
Packaging100 CAPSULE in 1 BOTTLE (31722-258-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722025828

NDC 931722-258
NDC 1031722-258-28
NDC Item31722025828
Packaging28 CAPSULE in 1 BOTTLE (31722-258-28)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 43598051101

NDC 943598-511
NDC 1043598-511-01
NDC Item43598051101
Packaging100 CAPSULE in 1 BOTTLE (43598-511-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051163

NDC 943598-511
NDC 1043598-511-63
NDC Item43598051163
Packaging28 CAPSULE in 1 BOTTLE (43598-511-63)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048401

NDC 947781-484
NDC 1047781-484-01
NDC Item47781048401
Packaging100 CAPSULE in 1 BOTTLE (47781-484-01)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 47781048428

NDC 947781-484
NDC 1047781-484-28
NDC Item47781048428
Packaging28 CAPSULE in 1 BOTTLE (47781-484-28)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034301

NDC 959651-343
NDC 1059651-343-01
NDC Item59651034301
Packaging100 CAPSULE in 1 BOTTLE (59651-343-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034307

NDC 959651-343
NDC 1059651-343-07
NDC Item59651034307
Packaging1 BLISTER PACK in 1 CARTON (59651-343-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034328

NDC 959651-343
NDC 1059651-343-28
NDC Item59651034328
Packaging28 CAPSULE in 1 BOTTLE (59651-343-28)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 60505453301

NDC 960505-4533
NDC 1060505-4533-1
NDC Item60505453301
Packaging100 CAPSULE in 1 BOTTLE (60505-4533-1)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453302

NDC 960505-4533
NDC 1060505-4533-2
NDC Item60505453302
Packaging28 CAPSULE in 1 BOTTLE (60505-4533-2)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004201

NDC 963304-042
NDC 1063304-042-01
NDC Item63304004201
Packaging100 CAPSULE in 1 BOTTLE (63304-042-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 63304004227

NDC 963304-042
NDC 1063304-042-27
NDC Item63304004227
Packaging28 CAPSULE in 1 BOTTLE (63304-042-27)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 69097038173

NDC 969097-381
NDC 1069097-381-73
NDC Item69097038173
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (69097-381-73)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla5mg;381
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 70710103101

NDC 970710-1031
NDC 1070710-1031-1
NDC Item70710103101
Packaging100 CAPSULE in 1 BOTTLE (70710-1031-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103107

NDC 970710-1031
NDC 1070710-1031-7
NDC Item70710103107
Packaging28 CAPSULE in 1 BOTTLE (70710-1031-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167701

NDC 970771-1677
NDC 1070771-1677-1
NDC Item70771167701
Packaging100 CAPSULE in 1 BOTTLE (70771-1677-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167707

NDC 970771-1677
NDC 1070771-1677-7
NDC Item70771167707
Packaging28 CAPSULE in 1 BOTTLE (70771-1677-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069748

NDC 976282-697
NDC 1076282-697-48
NDC Item76282069748
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (76282-697-48)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id792852
Imprint codeCipla5mg;381
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193601

NDC 90378-1936
NDC 100378-1936-01
NDC Item00378193601
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193628

NDC 90378-1936
NDC 100378-1936-28
NDC Item00378193628
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-28)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00480124228

NDC 90480-1242
NDC 100480-1242-28
NDC Item00480124228
Packaging28 CAPSULE in 1 BOTTLE (0480-1242-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;5mg
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 31722025801

NDC 931722-258
NDC 1031722-258-01
NDC Item31722025801
Packaging100 CAPSULE in 1 BOTTLE (31722-258-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722025828

NDC 931722-258
NDC 1031722-258-28
NDC Item31722025828
Packaging28 CAPSULE in 1 BOTTLE (31722-258-28)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 43598051101

NDC 943598-511
NDC 1043598-511-01
NDC Item43598051101
Packaging100 CAPSULE in 1 BOTTLE (43598-511-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051163

NDC 943598-511
NDC 1043598-511-63
NDC Item43598051163
Packaging28 CAPSULE in 1 BOTTLE (43598-511-63)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048401

NDC 947781-484
NDC 1047781-484-01
NDC Item47781048401
Packaging100 CAPSULE in 1 BOTTLE (47781-484-01)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 47781048428

NDC 947781-484
NDC 1047781-484-28
NDC Item47781048428
Packaging28 CAPSULE in 1 BOTTLE (47781-484-28)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034301

NDC 959651-343
NDC 1059651-343-01
NDC Item59651034301
Packaging100 CAPSULE in 1 BOTTLE (59651-343-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034307

NDC 959651-343
NDC 1059651-343-07
NDC Item59651034307
Packaging1 BLISTER PACK in 1 CARTON (59651-343-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034328

NDC 959651-343
NDC 1059651-343-28
NDC Item59651034328
Packaging28 CAPSULE in 1 BOTTLE (59651-343-28)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 60505453301

NDC 960505-4533
NDC 1060505-4533-1
NDC Item60505453301
Packaging100 CAPSULE in 1 BOTTLE (60505-4533-1)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453302

NDC 960505-4533
NDC 1060505-4533-2
NDC Item60505453302
Packaging28 CAPSULE in 1 BOTTLE (60505-4533-2)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004201

NDC 963304-042
NDC 1063304-042-01
NDC Item63304004201
Packaging100 CAPSULE in 1 BOTTLE (63304-042-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 63304004227

NDC 963304-042
NDC 1063304-042-27
NDC Item63304004227
Packaging28 CAPSULE in 1 BOTTLE (63304-042-27)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 69097038173

NDC 969097-381
NDC 1069097-381-73
NDC Item69097038173
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (69097-381-73)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla5mg;381
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 70710103101

NDC 970710-1031
NDC 1070710-1031-1
NDC Item70710103101
Packaging100 CAPSULE in 1 BOTTLE (70710-1031-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103107

NDC 970710-1031
NDC 1070710-1031-7
NDC Item70710103107
Packaging28 CAPSULE in 1 BOTTLE (70710-1031-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167701

NDC 970771-1677
NDC 1070771-1677-1
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Packaging100 CAPSULE in 1 BOTTLE (70771-1677-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167707

NDC 970771-1677
NDC 1070771-1677-7
NDC Item70771167707
Packaging28 CAPSULE in 1 BOTTLE (70771-1677-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069748

NDC 976282-697
NDC 1076282-697-48
NDC Item76282069748
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (76282-697-48)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id792852
Imprint codeCipla5mg;381
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193601

NDC 90378-1936
NDC 100378-1936-01
NDC Item00378193601
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193628

NDC 90378-1936
NDC 100378-1936-28
NDC Item00378193628
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-28)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00480124228

NDC 90480-1242
NDC 100480-1242-28
NDC Item00480124228
Packaging28 CAPSULE in 1 BOTTLE (0480-1242-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;5mg
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 31722025801

NDC 931722-258
NDC 1031722-258-01
NDC Item31722025801
Packaging100 CAPSULE in 1 BOTTLE (31722-258-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722025828

NDC 931722-258
NDC 1031722-258-28
NDC Item31722025828
Packaging28 CAPSULE in 1 BOTTLE (31722-258-28)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 43598051101

NDC 943598-511
NDC 1043598-511-01
NDC Item43598051101
Packaging100 CAPSULE in 1 BOTTLE (43598-511-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051163

NDC 943598-511
NDC 1043598-511-63
NDC Item43598051163
Packaging28 CAPSULE in 1 BOTTLE (43598-511-63)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048401

NDC 947781-484
NDC 1047781-484-01
NDC Item47781048401
Packaging100 CAPSULE in 1 BOTTLE (47781-484-01)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 47781048428

NDC 947781-484
NDC 1047781-484-28
NDC Item47781048428
Packaging28 CAPSULE in 1 BOTTLE (47781-484-28)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034301

NDC 959651-343
NDC 1059651-343-01
NDC Item59651034301
Packaging100 CAPSULE in 1 BOTTLE (59651-343-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034307

NDC 959651-343
NDC 1059651-343-07
NDC Item59651034307
Packaging1 BLISTER PACK in 1 CARTON (59651-343-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034328

NDC 959651-343
NDC 1059651-343-28
NDC Item59651034328
Packaging28 CAPSULE in 1 BOTTLE (59651-343-28)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 60505453301

NDC 960505-4533
NDC 1060505-4533-1
NDC Item60505453301
Packaging100 CAPSULE in 1 BOTTLE (60505-4533-1)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453302

NDC 960505-4533
NDC 1060505-4533-2
NDC Item60505453302
Packaging28 CAPSULE in 1 BOTTLE (60505-4533-2)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004201

NDC 963304-042
NDC 1063304-042-01
NDC Item63304004201
Packaging100 CAPSULE in 1 BOTTLE (63304-042-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 63304004227

NDC 963304-042
NDC 1063304-042-27
NDC Item63304004227
Packaging28 CAPSULE in 1 BOTTLE (63304-042-27)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 69097038173

NDC 969097-381
NDC 1069097-381-73
NDC Item69097038173
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (69097-381-73)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla5mg;381
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 70710103101

NDC 970710-1031
NDC 1070710-1031-1
NDC Item70710103101
Packaging100 CAPSULE in 1 BOTTLE (70710-1031-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103107

NDC 970710-1031
NDC 1070710-1031-7
NDC Item70710103107
Packaging28 CAPSULE in 1 BOTTLE (70710-1031-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167701

NDC 970771-1677
NDC 1070771-1677-1
NDC Item70771167701
Packaging100 CAPSULE in 1 BOTTLE (70771-1677-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167707

NDC 970771-1677
NDC 1070771-1677-7
NDC Item70771167707
Packaging28 CAPSULE in 1 BOTTLE (70771-1677-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069748

NDC 976282-697
NDC 1076282-697-48
NDC Item76282069748
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (76282-697-48)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id792852
Imprint codeCipla5mg;381
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193601

NDC 90378-1936
NDC 100378-1936-01
NDC Item00378193601
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193628

NDC 90378-1936
NDC 100378-1936-28
NDC Item00378193628
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-28)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00480124228

NDC 90480-1242
NDC 100480-1242-28
NDC Item00480124228
Packaging28 CAPSULE in 1 BOTTLE (0480-1242-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;5mg
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 31722025801

NDC 931722-258
NDC 1031722-258-01
NDC Item31722025801
Packaging100 CAPSULE in 1 BOTTLE (31722-258-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722025828

NDC 931722-258
NDC 1031722-258-28
NDC Item31722025828
Packaging28 CAPSULE in 1 BOTTLE (31722-258-28)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 43598051101

NDC 943598-511
NDC 1043598-511-01
NDC Item43598051101
Packaging100 CAPSULE in 1 BOTTLE (43598-511-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051163

NDC 943598-511
NDC 1043598-511-63
NDC Item43598051163
Packaging28 CAPSULE in 1 BOTTLE (43598-511-63)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048401

NDC 947781-484
NDC 1047781-484-01
NDC Item47781048401
Packaging100 CAPSULE in 1 BOTTLE (47781-484-01)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 47781048428

NDC 947781-484
NDC 1047781-484-28
NDC Item47781048428
Packaging28 CAPSULE in 1 BOTTLE (47781-484-28)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034301

NDC 959651-343
NDC 1059651-343-01
NDC Item59651034301
Packaging100 CAPSULE in 1 BOTTLE (59651-343-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034307

NDC 959651-343
NDC 1059651-343-07
NDC Item59651034307
Packaging1 BLISTER PACK in 1 CARTON (59651-343-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034328

NDC 959651-343
NDC 1059651-343-28
NDC Item59651034328
Packaging28 CAPSULE in 1 BOTTLE (59651-343-28)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 60505453301

NDC 960505-4533
NDC 1060505-4533-1
NDC Item60505453301
Packaging100 CAPSULE in 1 BOTTLE (60505-4533-1)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453302

NDC 960505-4533
NDC 1060505-4533-2
NDC Item60505453302
Packaging28 CAPSULE in 1 BOTTLE (60505-4533-2)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004201

NDC 963304-042
NDC 1063304-042-01
NDC Item63304004201
Packaging100 CAPSULE in 1 BOTTLE (63304-042-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 63304004227

NDC 963304-042
NDC 1063304-042-27
NDC Item63304004227
Packaging28 CAPSULE in 1 BOTTLE (63304-042-27)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 69097038173

NDC 969097-381
NDC 1069097-381-73
NDC Item69097038173
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (69097-381-73)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla5mg;381
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 70710103101

NDC 970710-1031
NDC 1070710-1031-1
NDC Item70710103101
Packaging100 CAPSULE in 1 BOTTLE (70710-1031-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103107

NDC 970710-1031
NDC 1070710-1031-7
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Packaging28 CAPSULE in 1 BOTTLE (70710-1031-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167701

NDC 970771-1677
NDC 1070771-1677-1
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Packaging100 CAPSULE in 1 BOTTLE (70771-1677-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167707

NDC 970771-1677
NDC 1070771-1677-7
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Packaging28 CAPSULE in 1 BOTTLE (70771-1677-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069748

NDC 976282-697
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Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (76282-697-48)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id792852
Imprint codeCipla5mg;381
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193601

NDC 90378-1936
NDC 100378-1936-01
NDC Item00378193601
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193628

NDC 90378-1936
NDC 100378-1936-28
NDC Item00378193628
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-28)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00480124228

NDC 90480-1242
NDC 100480-1242-28
NDC Item00480124228
Packaging28 CAPSULE in 1 BOTTLE (0480-1242-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;5mg
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 31722025801

NDC 931722-258
NDC 1031722-258-01
NDC Item31722025801
Packaging100 CAPSULE in 1 BOTTLE (31722-258-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722025828

NDC 931722-258
NDC 1031722-258-28
NDC Item31722025828
Packaging28 CAPSULE in 1 BOTTLE (31722-258-28)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 43598051101

NDC 943598-511
NDC 1043598-511-01
NDC Item43598051101
Packaging100 CAPSULE in 1 BOTTLE (43598-511-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051163

NDC 943598-511
NDC 1043598-511-63
NDC Item43598051163
Packaging28 CAPSULE in 1 BOTTLE (43598-511-63)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048401

NDC 947781-484
NDC 1047781-484-01
NDC Item47781048401
Packaging100 CAPSULE in 1 BOTTLE (47781-484-01)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 47781048428

NDC 947781-484
NDC 1047781-484-28
NDC Item47781048428
Packaging28 CAPSULE in 1 BOTTLE (47781-484-28)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034301

NDC 959651-343
NDC 1059651-343-01
NDC Item59651034301
Packaging100 CAPSULE in 1 BOTTLE (59651-343-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034307

NDC 959651-343
NDC 1059651-343-07
NDC Item59651034307
Packaging1 BLISTER PACK in 1 CARTON (59651-343-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034328

NDC 959651-343
NDC 1059651-343-28
NDC Item59651034328
Packaging28 CAPSULE in 1 BOTTLE (59651-343-28)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 60505453301

NDC 960505-4533
NDC 1060505-4533-1
NDC Item60505453301
Packaging100 CAPSULE in 1 BOTTLE (60505-4533-1)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453302

NDC 960505-4533
NDC 1060505-4533-2
NDC Item60505453302
Packaging28 CAPSULE in 1 BOTTLE (60505-4533-2)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004201

NDC 963304-042
NDC 1063304-042-01
NDC Item63304004201
Packaging100 CAPSULE in 1 BOTTLE (63304-042-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 63304004227

NDC 963304-042
NDC 1063304-042-27
NDC Item63304004227
Packaging28 CAPSULE in 1 BOTTLE (63304-042-27)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 69097038173

NDC 969097-381
NDC 1069097-381-73
NDC Item69097038173
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (69097-381-73)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla5mg;381
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 70710103101

NDC 970710-1031
NDC 1070710-1031-1
NDC Item70710103101
Packaging100 CAPSULE in 1 BOTTLE (70710-1031-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103107

NDC 970710-1031
NDC 1070710-1031-7
NDC Item70710103107
Packaging28 CAPSULE in 1 BOTTLE (70710-1031-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167701

NDC 970771-1677
NDC 1070771-1677-1
NDC Item70771167701
Packaging100 CAPSULE in 1 BOTTLE (70771-1677-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167707

NDC 970771-1677
NDC 1070771-1677-7
NDC Item70771167707
Packaging28 CAPSULE in 1 BOTTLE (70771-1677-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069748

NDC 976282-697
NDC 1076282-697-48
NDC Item76282069748
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (76282-697-48)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id792852
Imprint codeCipla5mg;381
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193601

NDC 90378-1936
NDC 100378-1936-01
NDC Item00378193601
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193628

NDC 90378-1936
NDC 100378-1936-28
NDC Item00378193628
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-28)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00480124228

NDC 90480-1242
NDC 100480-1242-28
NDC Item00480124228
Packaging28 CAPSULE in 1 BOTTLE (0480-1242-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;5mg
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 31722025801

NDC 931722-258
NDC 1031722-258-01
NDC Item31722025801
Packaging100 CAPSULE in 1 BOTTLE (31722-258-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722025828

NDC 931722-258
NDC 1031722-258-28
NDC Item31722025828
Packaging28 CAPSULE in 1 BOTTLE (31722-258-28)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 43598051101

NDC 943598-511
NDC 1043598-511-01
NDC Item43598051101
Packaging100 CAPSULE in 1 BOTTLE (43598-511-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051163

NDC 943598-511
NDC 1043598-511-63
NDC Item43598051163
Packaging28 CAPSULE in 1 BOTTLE (43598-511-63)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048401

NDC 947781-484
NDC 1047781-484-01
NDC Item47781048401
Packaging100 CAPSULE in 1 BOTTLE (47781-484-01)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 47781048428

NDC 947781-484
NDC 1047781-484-28
NDC Item47781048428
Packaging28 CAPSULE in 1 BOTTLE (47781-484-28)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034301

NDC 959651-343
NDC 1059651-343-01
NDC Item59651034301
Packaging100 CAPSULE in 1 BOTTLE (59651-343-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034307

NDC 959651-343
NDC 1059651-343-07
NDC Item59651034307
Packaging1 BLISTER PACK in 1 CARTON (59651-343-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034328

NDC 959651-343
NDC 1059651-343-28
NDC Item59651034328
Packaging28 CAPSULE in 1 BOTTLE (59651-343-28)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 60505453301

NDC 960505-4533
NDC 1060505-4533-1
NDC Item60505453301
Packaging100 CAPSULE in 1 BOTTLE (60505-4533-1)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453302

NDC 960505-4533
NDC 1060505-4533-2
NDC Item60505453302
Packaging28 CAPSULE in 1 BOTTLE (60505-4533-2)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004201

NDC 963304-042
NDC 1063304-042-01
NDC Item63304004201
Packaging100 CAPSULE in 1 BOTTLE (63304-042-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 63304004227

NDC 963304-042
NDC 1063304-042-27
NDC Item63304004227
Packaging28 CAPSULE in 1 BOTTLE (63304-042-27)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 69097038173

NDC 969097-381
NDC 1069097-381-73
NDC Item69097038173
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (69097-381-73)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla5mg;381
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 70710103101

NDC 970710-1031
NDC 1070710-1031-1
NDC Item70710103101
Packaging100 CAPSULE in 1 BOTTLE (70710-1031-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103107

NDC 970710-1031
NDC 1070710-1031-7
NDC Item70710103107
Packaging28 CAPSULE in 1 BOTTLE (70710-1031-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167701

NDC 970771-1677
NDC 1070771-1677-1
NDC Item70771167701
Packaging100 CAPSULE in 1 BOTTLE (70771-1677-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167707

NDC 970771-1677
NDC 1070771-1677-7
NDC Item70771167707
Packaging28 CAPSULE in 1 BOTTLE (70771-1677-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069748

NDC 976282-697
NDC 1076282-697-48
NDC Item76282069748
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (76282-697-48)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id792852
Imprint codeCipla5mg;381
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193601

NDC 90378-1936
NDC 100378-1936-01
NDC Item00378193601
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193628

NDC 90378-1936
NDC 100378-1936-28
NDC Item00378193628
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-28)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00480124228

NDC 90480-1242
NDC 100480-1242-28
NDC Item00480124228
Packaging28 CAPSULE in 1 BOTTLE (0480-1242-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;5mg
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 31722025801

NDC 931722-258
NDC 1031722-258-01
NDC Item31722025801
Packaging100 CAPSULE in 1 BOTTLE (31722-258-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722025828

NDC 931722-258
NDC 1031722-258-28
NDC Item31722025828
Packaging28 CAPSULE in 1 BOTTLE (31722-258-28)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 43598051101

NDC 943598-511
NDC 1043598-511-01
NDC Item43598051101
Packaging100 CAPSULE in 1 BOTTLE (43598-511-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051163

NDC 943598-511
NDC 1043598-511-63
NDC Item43598051163
Packaging28 CAPSULE in 1 BOTTLE (43598-511-63)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048401

NDC 947781-484
NDC 1047781-484-01
NDC Item47781048401
Packaging100 CAPSULE in 1 BOTTLE (47781-484-01)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 47781048428

NDC 947781-484
NDC 1047781-484-28
NDC Item47781048428
Packaging28 CAPSULE in 1 BOTTLE (47781-484-28)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034301

NDC 959651-343
NDC 1059651-343-01
NDC Item59651034301
Packaging100 CAPSULE in 1 BOTTLE (59651-343-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034307

NDC 959651-343
NDC 1059651-343-07
NDC Item59651034307
Packaging1 BLISTER PACK in 1 CARTON (59651-343-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034328

NDC 959651-343
NDC 1059651-343-28
NDC Item59651034328
Packaging28 CAPSULE in 1 BOTTLE (59651-343-28)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 60505453301

NDC 960505-4533
NDC 1060505-4533-1
NDC Item60505453301
Packaging100 CAPSULE in 1 BOTTLE (60505-4533-1)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453302

NDC 960505-4533
NDC 1060505-4533-2
NDC Item60505453302
Packaging28 CAPSULE in 1 BOTTLE (60505-4533-2)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004201

NDC 963304-042
NDC 1063304-042-01
NDC Item63304004201
Packaging100 CAPSULE in 1 BOTTLE (63304-042-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 63304004227

NDC 963304-042
NDC 1063304-042-27
NDC Item63304004227
Packaging28 CAPSULE in 1 BOTTLE (63304-042-27)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 69097038173

NDC 969097-381
NDC 1069097-381-73
NDC Item69097038173
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (69097-381-73)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla5mg;381
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 70710103101

NDC 970710-1031
NDC 1070710-1031-1
NDC Item70710103101
Packaging100 CAPSULE in 1 BOTTLE (70710-1031-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103107

NDC 970710-1031
NDC 1070710-1031-7
NDC Item70710103107
Packaging28 CAPSULE in 1 BOTTLE (70710-1031-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167701

NDC 970771-1677
NDC 1070771-1677-1
NDC Item70771167701
Packaging100 CAPSULE in 1 BOTTLE (70771-1677-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167707

NDC 970771-1677
NDC 1070771-1677-7
NDC Item70771167707
Packaging28 CAPSULE in 1 BOTTLE (70771-1677-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069748

NDC 976282-697
NDC 1076282-697-48
NDC Item76282069748
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (76282-697-48)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id792852
Imprint codeCipla5mg;381
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193601

NDC 90378-1936
NDC 100378-1936-01
NDC Item00378193601
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193628

NDC 90378-1936
NDC 100378-1936-28
NDC Item00378193628
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-28)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00480124228

NDC 90480-1242
NDC 100480-1242-28
NDC Item00480124228
Packaging28 CAPSULE in 1 BOTTLE (0480-1242-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;5mg
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 31722025801

NDC 931722-258
NDC 1031722-258-01
NDC Item31722025801
Packaging100 CAPSULE in 1 BOTTLE (31722-258-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722025828

NDC 931722-258
NDC 1031722-258-28
NDC Item31722025828
Packaging28 CAPSULE in 1 BOTTLE (31722-258-28)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 43598051101

NDC 943598-511
NDC 1043598-511-01
NDC Item43598051101
Packaging100 CAPSULE in 1 BOTTLE (43598-511-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051163

NDC 943598-511
NDC 1043598-511-63
NDC Item43598051163
Packaging28 CAPSULE in 1 BOTTLE (43598-511-63)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048401

NDC 947781-484
NDC 1047781-484-01
NDC Item47781048401
Packaging100 CAPSULE in 1 BOTTLE (47781-484-01)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 47781048428

NDC 947781-484
NDC 1047781-484-28
NDC Item47781048428
Packaging28 CAPSULE in 1 BOTTLE (47781-484-28)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034301

NDC 959651-343
NDC 1059651-343-01
NDC Item59651034301
Packaging100 CAPSULE in 1 BOTTLE (59651-343-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034307

NDC 959651-343
NDC 1059651-343-07
NDC Item59651034307
Packaging1 BLISTER PACK in 1 CARTON (59651-343-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034328

NDC 959651-343
NDC 1059651-343-28
NDC Item59651034328
Packaging28 CAPSULE in 1 BOTTLE (59651-343-28)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 60505453301

NDC 960505-4533
NDC 1060505-4533-1
NDC Item60505453301
Packaging100 CAPSULE in 1 BOTTLE (60505-4533-1)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453302

NDC 960505-4533
NDC 1060505-4533-2
NDC Item60505453302
Packaging28 CAPSULE in 1 BOTTLE (60505-4533-2)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004201

NDC 963304-042
NDC 1063304-042-01
NDC Item63304004201
Packaging100 CAPSULE in 1 BOTTLE (63304-042-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 63304004227

NDC 963304-042
NDC 1063304-042-27
NDC Item63304004227
Packaging28 CAPSULE in 1 BOTTLE (63304-042-27)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 69097038173

NDC 969097-381
NDC 1069097-381-73
NDC Item69097038173
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (69097-381-73)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla5mg;381
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 70710103101

NDC 970710-1031
NDC 1070710-1031-1
NDC Item70710103101
Packaging100 CAPSULE in 1 BOTTLE (70710-1031-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103107

NDC 970710-1031
NDC 1070710-1031-7
NDC Item70710103107
Packaging28 CAPSULE in 1 BOTTLE (70710-1031-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167701

NDC 970771-1677
NDC 1070771-1677-1
NDC Item70771167701
Packaging100 CAPSULE in 1 BOTTLE (70771-1677-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167707

NDC 970771-1677
NDC 1070771-1677-7
NDC Item70771167707
Packaging28 CAPSULE in 1 BOTTLE (70771-1677-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069748

NDC 976282-697
NDC 1076282-697-48
NDC Item76282069748
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (76282-697-48)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id792852
Imprint codeCipla5mg;381
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193601

NDC 90378-1936
NDC 100378-1936-01
NDC Item00378193601
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193628

NDC 90378-1936
NDC 100378-1936-28
NDC Item00378193628
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-28)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00480124228

NDC 90480-1242
NDC 100480-1242-28
NDC Item00480124228
Packaging28 CAPSULE in 1 BOTTLE (0480-1242-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;5mg
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 31722025801

NDC 931722-258
NDC 1031722-258-01
NDC Item31722025801
Packaging100 CAPSULE in 1 BOTTLE (31722-258-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722025828

NDC 931722-258
NDC 1031722-258-28
NDC Item31722025828
Packaging28 CAPSULE in 1 BOTTLE (31722-258-28)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 43598051101

NDC 943598-511
NDC 1043598-511-01
NDC Item43598051101
Packaging100 CAPSULE in 1 BOTTLE (43598-511-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051163

NDC 943598-511
NDC 1043598-511-63
NDC Item43598051163
Packaging28 CAPSULE in 1 BOTTLE (43598-511-63)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048401

NDC 947781-484
NDC 1047781-484-01
NDC Item47781048401
Packaging100 CAPSULE in 1 BOTTLE (47781-484-01)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 47781048428

NDC 947781-484
NDC 1047781-484-28
NDC Item47781048428
Packaging28 CAPSULE in 1 BOTTLE (47781-484-28)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034301

NDC 959651-343
NDC 1059651-343-01
NDC Item59651034301
Packaging100 CAPSULE in 1 BOTTLE (59651-343-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034307

NDC 959651-343
NDC 1059651-343-07
NDC Item59651034307
Packaging1 BLISTER PACK in 1 CARTON (59651-343-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034328

NDC 959651-343
NDC 1059651-343-28
NDC Item59651034328
Packaging28 CAPSULE in 1 BOTTLE (59651-343-28)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 60505453301

NDC 960505-4533
NDC 1060505-4533-1
NDC Item60505453301
Packaging100 CAPSULE in 1 BOTTLE (60505-4533-1)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453302

NDC 960505-4533
NDC 1060505-4533-2
NDC Item60505453302
Packaging28 CAPSULE in 1 BOTTLE (60505-4533-2)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004201

NDC 963304-042
NDC 1063304-042-01
NDC Item63304004201
Packaging100 CAPSULE in 1 BOTTLE (63304-042-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 63304004227

NDC 963304-042
NDC 1063304-042-27
NDC Item63304004227
Packaging28 CAPSULE in 1 BOTTLE (63304-042-27)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 69097038173

NDC 969097-381
NDC 1069097-381-73
NDC Item69097038173
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (69097-381-73)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla5mg;381
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 70710103101

NDC 970710-1031
NDC 1070710-1031-1
NDC Item70710103101
Packaging100 CAPSULE in 1 BOTTLE (70710-1031-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103107

NDC 970710-1031
NDC 1070710-1031-7
NDC Item70710103107
Packaging28 CAPSULE in 1 BOTTLE (70710-1031-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167701

NDC 970771-1677
NDC 1070771-1677-1
NDC Item70771167701
Packaging100 CAPSULE in 1 BOTTLE (70771-1677-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167707

NDC 970771-1677
NDC 1070771-1677-7
NDC Item70771167707
Packaging28 CAPSULE in 1 BOTTLE (70771-1677-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069748

NDC 976282-697
NDC 1076282-697-48
NDC Item76282069748
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (76282-697-48)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id792852
Imprint codeCipla5mg;381
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193601

NDC 90378-1936
NDC 100378-1936-01
NDC Item00378193601
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193628

NDC 90378-1936
NDC 100378-1936-28
NDC Item00378193628
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-28)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00480124228

NDC 90480-1242
NDC 100480-1242-28
NDC Item00480124228
Packaging28 CAPSULE in 1 BOTTLE (0480-1242-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;5mg
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 31722025801

NDC 931722-258
NDC 1031722-258-01
NDC Item31722025801
Packaging100 CAPSULE in 1 BOTTLE (31722-258-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722025828

NDC 931722-258
NDC 1031722-258-28
NDC Item31722025828
Packaging28 CAPSULE in 1 BOTTLE (31722-258-28)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 43598051101

NDC 943598-511
NDC 1043598-511-01
NDC Item43598051101
Packaging100 CAPSULE in 1 BOTTLE (43598-511-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051163

NDC 943598-511
NDC 1043598-511-63
NDC Item43598051163
Packaging28 CAPSULE in 1 BOTTLE (43598-511-63)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048401

NDC 947781-484
NDC 1047781-484-01
NDC Item47781048401
Packaging100 CAPSULE in 1 BOTTLE (47781-484-01)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 47781048428

NDC 947781-484
NDC 1047781-484-28
NDC Item47781048428
Packaging28 CAPSULE in 1 BOTTLE (47781-484-28)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034301

NDC 959651-343
NDC 1059651-343-01
NDC Item59651034301
Packaging100 CAPSULE in 1 BOTTLE (59651-343-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034307

NDC 959651-343
NDC 1059651-343-07
NDC Item59651034307
Packaging1 BLISTER PACK in 1 CARTON (59651-343-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034328

NDC 959651-343
NDC 1059651-343-28
NDC Item59651034328
Packaging28 CAPSULE in 1 BOTTLE (59651-343-28)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 60505453301

NDC 960505-4533
NDC 1060505-4533-1
NDC Item60505453301
Packaging100 CAPSULE in 1 BOTTLE (60505-4533-1)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453302

NDC 960505-4533
NDC 1060505-4533-2
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Packaging28 CAPSULE in 1 BOTTLE (60505-4533-2)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004201

NDC 963304-042
NDC 1063304-042-01
NDC Item63304004201
Packaging100 CAPSULE in 1 BOTTLE (63304-042-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 63304004227

NDC 963304-042
NDC 1063304-042-27
NDC Item63304004227
Packaging28 CAPSULE in 1 BOTTLE (63304-042-27)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 69097038173

NDC 969097-381
NDC 1069097-381-73
NDC Item69097038173
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (69097-381-73)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla5mg;381
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 70710103101

NDC 970710-1031
NDC 1070710-1031-1
NDC Item70710103101
Packaging100 CAPSULE in 1 BOTTLE (70710-1031-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103107

NDC 970710-1031
NDC 1070710-1031-7
NDC Item70710103107
Packaging28 CAPSULE in 1 BOTTLE (70710-1031-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167701

NDC 970771-1677
NDC 1070771-1677-1
NDC Item70771167701
Packaging100 CAPSULE in 1 BOTTLE (70771-1677-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167707

NDC 970771-1677
NDC 1070771-1677-7
NDC Item70771167707
Packaging28 CAPSULE in 1 BOTTLE (70771-1677-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069748

NDC 976282-697
NDC 1076282-697-48
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Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (76282-697-48)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id792852
Imprint codeCipla5mg;381
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193601

NDC 90378-1936
NDC 100378-1936-01
NDC Item00378193601
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193628

NDC 90378-1936
NDC 100378-1936-28
NDC Item00378193628
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-28)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00480124228

NDC 90480-1242
NDC 100480-1242-28
NDC Item00480124228
Packaging28 CAPSULE in 1 BOTTLE (0480-1242-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;5mg
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 31722025801

NDC 931722-258
NDC 1031722-258-01
NDC Item31722025801
Packaging100 CAPSULE in 1 BOTTLE (31722-258-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722025828

NDC 931722-258
NDC 1031722-258-28
NDC Item31722025828
Packaging28 CAPSULE in 1 BOTTLE (31722-258-28)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 43598051101

NDC 943598-511
NDC 1043598-511-01
NDC Item43598051101
Packaging100 CAPSULE in 1 BOTTLE (43598-511-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051163

NDC 943598-511
NDC 1043598-511-63
NDC Item43598051163
Packaging28 CAPSULE in 1 BOTTLE (43598-511-63)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048401

NDC 947781-484
NDC 1047781-484-01
NDC Item47781048401
Packaging100 CAPSULE in 1 BOTTLE (47781-484-01)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 47781048428

NDC 947781-484
NDC 1047781-484-28
NDC Item47781048428
Packaging28 CAPSULE in 1 BOTTLE (47781-484-28)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034301

NDC 959651-343
NDC 1059651-343-01
NDC Item59651034301
Packaging100 CAPSULE in 1 BOTTLE (59651-343-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034307

NDC 959651-343
NDC 1059651-343-07
NDC Item59651034307
Packaging1 BLISTER PACK in 1 CARTON (59651-343-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034328

NDC 959651-343
NDC 1059651-343-28
NDC Item59651034328
Packaging28 CAPSULE in 1 BOTTLE (59651-343-28)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 60505453301

NDC 960505-4533
NDC 1060505-4533-1
NDC Item60505453301
Packaging100 CAPSULE in 1 BOTTLE (60505-4533-1)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453302

NDC 960505-4533
NDC 1060505-4533-2
NDC Item60505453302
Packaging28 CAPSULE in 1 BOTTLE (60505-4533-2)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004201

NDC 963304-042
NDC 1063304-042-01
NDC Item63304004201
Packaging100 CAPSULE in 1 BOTTLE (63304-042-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 63304004227

NDC 963304-042
NDC 1063304-042-27
NDC Item63304004227
Packaging28 CAPSULE in 1 BOTTLE (63304-042-27)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 69097038173

NDC 969097-381
NDC 1069097-381-73
NDC Item69097038173
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (69097-381-73)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla5mg;381
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 70710103101

NDC 970710-1031
NDC 1070710-1031-1
NDC Item70710103101
Packaging100 CAPSULE in 1 BOTTLE (70710-1031-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103107

NDC 970710-1031
NDC 1070710-1031-7
NDC Item70710103107
Packaging28 CAPSULE in 1 BOTTLE (70710-1031-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167701

NDC 970771-1677
NDC 1070771-1677-1
NDC Item70771167701
Packaging100 CAPSULE in 1 BOTTLE (70771-1677-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167707

NDC 970771-1677
NDC 1070771-1677-7
NDC Item70771167707
Packaging28 CAPSULE in 1 BOTTLE (70771-1677-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069748

NDC 976282-697
NDC 1076282-697-48
NDC Item76282069748
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (76282-697-48)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id792852
Imprint codeCipla5mg;381
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193601

NDC 90378-1936
NDC 100378-1936-01
NDC Item00378193601
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193628

NDC 90378-1936
NDC 100378-1936-28
NDC Item00378193628
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-28)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00480124228

NDC 90480-1242
NDC 100480-1242-28
NDC Item00480124228
Packaging28 CAPSULE in 1 BOTTLE (0480-1242-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;5mg
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 31722025801

NDC 931722-258
NDC 1031722-258-01
NDC Item31722025801
Packaging100 CAPSULE in 1 BOTTLE (31722-258-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722025828

NDC 931722-258
NDC 1031722-258-28
NDC Item31722025828
Packaging28 CAPSULE in 1 BOTTLE (31722-258-28)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 43598051101

NDC 943598-511
NDC 1043598-511-01
NDC Item43598051101
Packaging100 CAPSULE in 1 BOTTLE (43598-511-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051163

NDC 943598-511
NDC 1043598-511-63
NDC Item43598051163
Packaging28 CAPSULE in 1 BOTTLE (43598-511-63)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048401

NDC 947781-484
NDC 1047781-484-01
NDC Item47781048401
Packaging100 CAPSULE in 1 BOTTLE (47781-484-01)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 47781048428

NDC 947781-484
NDC 1047781-484-28
NDC Item47781048428
Packaging28 CAPSULE in 1 BOTTLE (47781-484-28)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034301

NDC 959651-343
NDC 1059651-343-01
NDC Item59651034301
Packaging100 CAPSULE in 1 BOTTLE (59651-343-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034307

NDC 959651-343
NDC 1059651-343-07
NDC Item59651034307
Packaging1 BLISTER PACK in 1 CARTON (59651-343-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034328

NDC 959651-343
NDC 1059651-343-28
NDC Item59651034328
Packaging28 CAPSULE in 1 BOTTLE (59651-343-28)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 60505453301

NDC 960505-4533
NDC 1060505-4533-1
NDC Item60505453301
Packaging100 CAPSULE in 1 BOTTLE (60505-4533-1)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453302

NDC 960505-4533
NDC 1060505-4533-2
NDC Item60505453302
Packaging28 CAPSULE in 1 BOTTLE (60505-4533-2)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004201

NDC 963304-042
NDC 1063304-042-01
NDC Item63304004201
Packaging100 CAPSULE in 1 BOTTLE (63304-042-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 63304004227

NDC 963304-042
NDC 1063304-042-27
NDC Item63304004227
Packaging28 CAPSULE in 1 BOTTLE (63304-042-27)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 69097038173

NDC 969097-381
NDC 1069097-381-73
NDC Item69097038173
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (69097-381-73)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla5mg;381
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 70710103101

NDC 970710-1031
NDC 1070710-1031-1
NDC Item70710103101
Packaging100 CAPSULE in 1 BOTTLE (70710-1031-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103107

NDC 970710-1031
NDC 1070710-1031-7
NDC Item70710103107
Packaging28 CAPSULE in 1 BOTTLE (70710-1031-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167701

NDC 970771-1677
NDC 1070771-1677-1
NDC Item70771167701
Packaging100 CAPSULE in 1 BOTTLE (70771-1677-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167707

NDC 970771-1677
NDC 1070771-1677-7
NDC Item70771167707
Packaging28 CAPSULE in 1 BOTTLE (70771-1677-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069748

NDC 976282-697
NDC 1076282-697-48
NDC Item76282069748
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (76282-697-48)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id792852
Imprint codeCipla5mg;381
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193601

NDC 90378-1936
NDC 100378-1936-01
NDC Item00378193601
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193628

NDC 90378-1936
NDC 100378-1936-28
NDC Item00378193628
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-28)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00480124228

NDC 90480-1242
NDC 100480-1242-28
NDC Item00480124228
Packaging28 CAPSULE in 1 BOTTLE (0480-1242-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;5mg
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 31722025801

NDC 931722-258
NDC 1031722-258-01
NDC Item31722025801
Packaging100 CAPSULE in 1 BOTTLE (31722-258-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722025828

NDC 931722-258
NDC 1031722-258-28
NDC Item31722025828
Packaging28 CAPSULE in 1 BOTTLE (31722-258-28)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 43598051101

NDC 943598-511
NDC 1043598-511-01
NDC Item43598051101
Packaging100 CAPSULE in 1 BOTTLE (43598-511-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051163

NDC 943598-511
NDC 1043598-511-63
NDC Item43598051163
Packaging28 CAPSULE in 1 BOTTLE (43598-511-63)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048401

NDC 947781-484
NDC 1047781-484-01
NDC Item47781048401
Packaging100 CAPSULE in 1 BOTTLE (47781-484-01)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 47781048428

NDC 947781-484
NDC 1047781-484-28
NDC Item47781048428
Packaging28 CAPSULE in 1 BOTTLE (47781-484-28)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034301

NDC 959651-343
NDC 1059651-343-01
NDC Item59651034301
Packaging100 CAPSULE in 1 BOTTLE (59651-343-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034307

NDC 959651-343
NDC 1059651-343-07
NDC Item59651034307
Packaging1 BLISTER PACK in 1 CARTON (59651-343-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034328

NDC 959651-343
NDC 1059651-343-28
NDC Item59651034328
Packaging28 CAPSULE in 1 BOTTLE (59651-343-28)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 60505453301

NDC 960505-4533
NDC 1060505-4533-1
NDC Item60505453301
Packaging100 CAPSULE in 1 BOTTLE (60505-4533-1)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453302

NDC 960505-4533
NDC 1060505-4533-2
NDC Item60505453302
Packaging28 CAPSULE in 1 BOTTLE (60505-4533-2)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004201

NDC 963304-042
NDC 1063304-042-01
NDC Item63304004201
Packaging100 CAPSULE in 1 BOTTLE (63304-042-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 63304004227

NDC 963304-042
NDC 1063304-042-27
NDC Item63304004227
Packaging28 CAPSULE in 1 BOTTLE (63304-042-27)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 69097038173

NDC 969097-381
NDC 1069097-381-73
NDC Item69097038173
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (69097-381-73)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla5mg;381
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 70710103101

NDC 970710-1031
NDC 1070710-1031-1
NDC Item70710103101
Packaging100 CAPSULE in 1 BOTTLE (70710-1031-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103107

NDC 970710-1031
NDC 1070710-1031-7
NDC Item70710103107
Packaging28 CAPSULE in 1 BOTTLE (70710-1031-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167701

NDC 970771-1677
NDC 1070771-1677-1
NDC Item70771167701
Packaging100 CAPSULE in 1 BOTTLE (70771-1677-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167707

NDC 970771-1677
NDC 1070771-1677-7
NDC Item70771167707
Packaging28 CAPSULE in 1 BOTTLE (70771-1677-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069748

NDC 976282-697
NDC 1076282-697-48
NDC Item76282069748
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (76282-697-48)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id792852
Imprint codeCipla5mg;381
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193601

NDC 90378-1936
NDC 100378-1936-01
NDC Item00378193601
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193628

NDC 90378-1936
NDC 100378-1936-28
NDC Item00378193628
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-28)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00480124228

NDC 90480-1242
NDC 100480-1242-28
NDC Item00480124228
Packaging28 CAPSULE in 1 BOTTLE (0480-1242-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;5mg
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 31722025801

NDC 931722-258
NDC 1031722-258-01
NDC Item31722025801
Packaging100 CAPSULE in 1 BOTTLE (31722-258-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722025828

NDC 931722-258
NDC 1031722-258-28
NDC Item31722025828
Packaging28 CAPSULE in 1 BOTTLE (31722-258-28)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 43598051101

NDC 943598-511
NDC 1043598-511-01
NDC Item43598051101
Packaging100 CAPSULE in 1 BOTTLE (43598-511-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051163

NDC 943598-511
NDC 1043598-511-63
NDC Item43598051163
Packaging28 CAPSULE in 1 BOTTLE (43598-511-63)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048401

NDC 947781-484
NDC 1047781-484-01
NDC Item47781048401
Packaging100 CAPSULE in 1 BOTTLE (47781-484-01)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 47781048428

NDC 947781-484
NDC 1047781-484-28
NDC Item47781048428
Packaging28 CAPSULE in 1 BOTTLE (47781-484-28)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034301

NDC 959651-343
NDC 1059651-343-01
NDC Item59651034301
Packaging100 CAPSULE in 1 BOTTLE (59651-343-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034307

NDC 959651-343
NDC 1059651-343-07
NDC Item59651034307
Packaging1 BLISTER PACK in 1 CARTON (59651-343-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034328

NDC 959651-343
NDC 1059651-343-28
NDC Item59651034328
Packaging28 CAPSULE in 1 BOTTLE (59651-343-28)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 60505453301

NDC 960505-4533
NDC 1060505-4533-1
NDC Item60505453301
Packaging100 CAPSULE in 1 BOTTLE (60505-4533-1)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453302

NDC 960505-4533
NDC 1060505-4533-2
NDC Item60505453302
Packaging28 CAPSULE in 1 BOTTLE (60505-4533-2)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004201

NDC 963304-042
NDC 1063304-042-01
NDC Item63304004201
Packaging100 CAPSULE in 1 BOTTLE (63304-042-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 63304004227

NDC 963304-042
NDC 1063304-042-27
NDC Item63304004227
Packaging28 CAPSULE in 1 BOTTLE (63304-042-27)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 69097038173

NDC 969097-381
NDC 1069097-381-73
NDC Item69097038173
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (69097-381-73)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla5mg;381
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 70710103101

NDC 970710-1031
NDC 1070710-1031-1
NDC Item70710103101
Packaging100 CAPSULE in 1 BOTTLE (70710-1031-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103107

NDC 970710-1031
NDC 1070710-1031-7
NDC Item70710103107
Packaging28 CAPSULE in 1 BOTTLE (70710-1031-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167701

NDC 970771-1677
NDC 1070771-1677-1
NDC Item70771167701
Packaging100 CAPSULE in 1 BOTTLE (70771-1677-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167707

NDC 970771-1677
NDC 1070771-1677-7
NDC Item70771167707
Packaging28 CAPSULE in 1 BOTTLE (70771-1677-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069748

NDC 976282-697
NDC 1076282-697-48
NDC Item76282069748
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (76282-697-48)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id792852
Imprint codeCipla5mg;381
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193601

NDC 90378-1936
NDC 100378-1936-01
NDC Item00378193601
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193628

NDC 90378-1936
NDC 100378-1936-28
NDC Item00378193628
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-28)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00480124228

NDC 90480-1242
NDC 100480-1242-28
NDC Item00480124228
Packaging28 CAPSULE in 1 BOTTLE (0480-1242-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;5mg
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 31722025801

NDC 931722-258
NDC 1031722-258-01
NDC Item31722025801
Packaging100 CAPSULE in 1 BOTTLE (31722-258-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722025828

NDC 931722-258
NDC 1031722-258-28
NDC Item31722025828
Packaging28 CAPSULE in 1 BOTTLE (31722-258-28)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 43598051101

NDC 943598-511
NDC 1043598-511-01
NDC Item43598051101
Packaging100 CAPSULE in 1 BOTTLE (43598-511-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051163

NDC 943598-511
NDC 1043598-511-63
NDC Item43598051163
Packaging28 CAPSULE in 1 BOTTLE (43598-511-63)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048401

NDC 947781-484
NDC 1047781-484-01
NDC Item47781048401
Packaging100 CAPSULE in 1 BOTTLE (47781-484-01)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 47781048428

NDC 947781-484
NDC 1047781-484-28
NDC Item47781048428
Packaging28 CAPSULE in 1 BOTTLE (47781-484-28)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034301

NDC 959651-343
NDC 1059651-343-01
NDC Item59651034301
Packaging100 CAPSULE in 1 BOTTLE (59651-343-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034307

NDC 959651-343
NDC 1059651-343-07
NDC Item59651034307
Packaging1 BLISTER PACK in 1 CARTON (59651-343-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034328

NDC 959651-343
NDC 1059651-343-28
NDC Item59651034328
Packaging28 CAPSULE in 1 BOTTLE (59651-343-28)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 60505453301

NDC 960505-4533
NDC 1060505-4533-1
NDC Item60505453301
Packaging100 CAPSULE in 1 BOTTLE (60505-4533-1)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453302

NDC 960505-4533
NDC 1060505-4533-2
NDC Item60505453302
Packaging28 CAPSULE in 1 BOTTLE (60505-4533-2)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004201

NDC 963304-042
NDC 1063304-042-01
NDC Item63304004201
Packaging100 CAPSULE in 1 BOTTLE (63304-042-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 63304004227

NDC 963304-042
NDC 1063304-042-27
NDC Item63304004227
Packaging28 CAPSULE in 1 BOTTLE (63304-042-27)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 69097038173

NDC 969097-381
NDC 1069097-381-73
NDC Item69097038173
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (69097-381-73)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla5mg;381
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 70710103101

NDC 970710-1031
NDC 1070710-1031-1
NDC Item70710103101
Packaging100 CAPSULE in 1 BOTTLE (70710-1031-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103107

NDC 970710-1031
NDC 1070710-1031-7
NDC Item70710103107
Packaging28 CAPSULE in 1 BOTTLE (70710-1031-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167701

NDC 970771-1677
NDC 1070771-1677-1
NDC Item70771167701
Packaging100 CAPSULE in 1 BOTTLE (70771-1677-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167707

NDC 970771-1677
NDC 1070771-1677-7
NDC Item70771167707
Packaging28 CAPSULE in 1 BOTTLE (70771-1677-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069748

NDC 976282-697
NDC 1076282-697-48
NDC Item76282069748
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (76282-697-48)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id792852
Imprint codeCipla5mg;381
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193601

NDC 90378-1936
NDC 100378-1936-01
NDC Item00378193601
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193628

NDC 90378-1936
NDC 100378-1936-28
NDC Item00378193628
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-28)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00480124228

NDC 90480-1242
NDC 100480-1242-28
NDC Item00480124228
Packaging28 CAPSULE in 1 BOTTLE (0480-1242-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;5mg
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 31722025801

NDC 931722-258
NDC 1031722-258-01
NDC Item31722025801
Packaging100 CAPSULE in 1 BOTTLE (31722-258-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722025828

NDC 931722-258
NDC 1031722-258-28
NDC Item31722025828
Packaging28 CAPSULE in 1 BOTTLE (31722-258-28)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 43598051101

NDC 943598-511
NDC 1043598-511-01
NDC Item43598051101
Packaging100 CAPSULE in 1 BOTTLE (43598-511-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051163

NDC 943598-511
NDC 1043598-511-63
NDC Item43598051163
Packaging28 CAPSULE in 1 BOTTLE (43598-511-63)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048401

NDC 947781-484
NDC 1047781-484-01
NDC Item47781048401
Packaging100 CAPSULE in 1 BOTTLE (47781-484-01)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 47781048428

NDC 947781-484
NDC 1047781-484-28
NDC Item47781048428
Packaging28 CAPSULE in 1 BOTTLE (47781-484-28)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034301

NDC 959651-343
NDC 1059651-343-01
NDC Item59651034301
Packaging100 CAPSULE in 1 BOTTLE (59651-343-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034307

NDC 959651-343
NDC 1059651-343-07
NDC Item59651034307
Packaging1 BLISTER PACK in 1 CARTON (59651-343-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034328

NDC 959651-343
NDC 1059651-343-28
NDC Item59651034328
Packaging28 CAPSULE in 1 BOTTLE (59651-343-28)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 60505453301

NDC 960505-4533
NDC 1060505-4533-1
NDC Item60505453301
Packaging100 CAPSULE in 1 BOTTLE (60505-4533-1)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453302

NDC 960505-4533
NDC 1060505-4533-2
NDC Item60505453302
Packaging28 CAPSULE in 1 BOTTLE (60505-4533-2)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004201

NDC 963304-042
NDC 1063304-042-01
NDC Item63304004201
Packaging100 CAPSULE in 1 BOTTLE (63304-042-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 63304004227

NDC 963304-042
NDC 1063304-042-27
NDC Item63304004227
Packaging28 CAPSULE in 1 BOTTLE (63304-042-27)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 69097038173

NDC 969097-381
NDC 1069097-381-73
NDC Item69097038173
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (69097-381-73)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla5mg;381
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 70710103101

NDC 970710-1031
NDC 1070710-1031-1
NDC Item70710103101
Packaging100 CAPSULE in 1 BOTTLE (70710-1031-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103107

NDC 970710-1031
NDC 1070710-1031-7
NDC Item70710103107
Packaging28 CAPSULE in 1 BOTTLE (70710-1031-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167701

NDC 970771-1677
NDC 1070771-1677-1
NDC Item70771167701
Packaging100 CAPSULE in 1 BOTTLE (70771-1677-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167707

NDC 970771-1677
NDC 1070771-1677-7
NDC Item70771167707
Packaging28 CAPSULE in 1 BOTTLE (70771-1677-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069748

NDC 976282-697
NDC 1076282-697-48
NDC Item76282069748
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (76282-697-48)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id792852
Imprint codeCipla5mg;381
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193601

NDC 90378-1936
NDC 100378-1936-01
NDC Item00378193601
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193628

NDC 90378-1936
NDC 100378-1936-28
NDC Item00378193628
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-28)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00480124228

NDC 90480-1242
NDC 100480-1242-28
NDC Item00480124228
Packaging28 CAPSULE in 1 BOTTLE (0480-1242-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;5mg
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 31722025801

NDC 931722-258
NDC 1031722-258-01
NDC Item31722025801
Packaging100 CAPSULE in 1 BOTTLE (31722-258-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722025828

NDC 931722-258
NDC 1031722-258-28
NDC Item31722025828
Packaging28 CAPSULE in 1 BOTTLE (31722-258-28)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 43598051101

NDC 943598-511
NDC 1043598-511-01
NDC Item43598051101
Packaging100 CAPSULE in 1 BOTTLE (43598-511-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051163

NDC 943598-511
NDC 1043598-511-63
NDC Item43598051163
Packaging28 CAPSULE in 1 BOTTLE (43598-511-63)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048401

NDC 947781-484
NDC 1047781-484-01
NDC Item47781048401
Packaging100 CAPSULE in 1 BOTTLE (47781-484-01)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 47781048428

NDC 947781-484
NDC 1047781-484-28
NDC Item47781048428
Packaging28 CAPSULE in 1 BOTTLE (47781-484-28)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034301

NDC 959651-343
NDC 1059651-343-01
NDC Item59651034301
Packaging100 CAPSULE in 1 BOTTLE (59651-343-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034307

NDC 959651-343
NDC 1059651-343-07
NDC Item59651034307
Packaging1 BLISTER PACK in 1 CARTON (59651-343-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034328

NDC 959651-343
NDC 1059651-343-28
NDC Item59651034328
Packaging28 CAPSULE in 1 BOTTLE (59651-343-28)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 60505453301

NDC 960505-4533
NDC 1060505-4533-1
NDC Item60505453301
Packaging100 CAPSULE in 1 BOTTLE (60505-4533-1)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453302

NDC 960505-4533
NDC 1060505-4533-2
NDC Item60505453302
Packaging28 CAPSULE in 1 BOTTLE (60505-4533-2)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004201

NDC 963304-042
NDC 1063304-042-01
NDC Item63304004201
Packaging100 CAPSULE in 1 BOTTLE (63304-042-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 63304004227

NDC 963304-042
NDC 1063304-042-27
NDC Item63304004227
Packaging28 CAPSULE in 1 BOTTLE (63304-042-27)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 69097038173

NDC 969097-381
NDC 1069097-381-73
NDC Item69097038173
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (69097-381-73)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla5mg;381
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 70710103101

NDC 970710-1031
NDC 1070710-1031-1
NDC Item70710103101
Packaging100 CAPSULE in 1 BOTTLE (70710-1031-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103107

NDC 970710-1031
NDC 1070710-1031-7
NDC Item70710103107
Packaging28 CAPSULE in 1 BOTTLE (70710-1031-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167701

NDC 970771-1677
NDC 1070771-1677-1
NDC Item70771167701
Packaging100 CAPSULE in 1 BOTTLE (70771-1677-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167707

NDC 970771-1677
NDC 1070771-1677-7
NDC Item70771167707
Packaging28 CAPSULE in 1 BOTTLE (70771-1677-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069748

NDC 976282-697
NDC 1076282-697-48
NDC Item76282069748
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (76282-697-48)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id792852
Imprint codeCipla5mg;381
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193601

NDC 90378-1936
NDC 100378-1936-01
NDC Item00378193601
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193628

NDC 90378-1936
NDC 100378-1936-28
NDC Item00378193628
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-28)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00480124228

NDC 90480-1242
NDC 100480-1242-28
NDC Item00480124228
Packaging28 CAPSULE in 1 BOTTLE (0480-1242-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;5mg
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 31722025801

NDC 931722-258
NDC 1031722-258-01
NDC Item31722025801
Packaging100 CAPSULE in 1 BOTTLE (31722-258-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722025828

NDC 931722-258
NDC 1031722-258-28
NDC Item31722025828
Packaging28 CAPSULE in 1 BOTTLE (31722-258-28)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 43598051101

NDC 943598-511
NDC 1043598-511-01
NDC Item43598051101
Packaging100 CAPSULE in 1 BOTTLE (43598-511-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051163

NDC 943598-511
NDC 1043598-511-63
NDC Item43598051163
Packaging28 CAPSULE in 1 BOTTLE (43598-511-63)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048401

NDC 947781-484
NDC 1047781-484-01
NDC Item47781048401
Packaging100 CAPSULE in 1 BOTTLE (47781-484-01)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 47781048428

NDC 947781-484
NDC 1047781-484-28
NDC Item47781048428
Packaging28 CAPSULE in 1 BOTTLE (47781-484-28)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034301

NDC 959651-343
NDC 1059651-343-01
NDC Item59651034301
Packaging100 CAPSULE in 1 BOTTLE (59651-343-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034307

NDC 959651-343
NDC 1059651-343-07
NDC Item59651034307
Packaging1 BLISTER PACK in 1 CARTON (59651-343-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034328

NDC 959651-343
NDC 1059651-343-28
NDC Item59651034328
Packaging28 CAPSULE in 1 BOTTLE (59651-343-28)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 60505453301

NDC 960505-4533
NDC 1060505-4533-1
NDC Item60505453301
Packaging100 CAPSULE in 1 BOTTLE (60505-4533-1)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453302

NDC 960505-4533
NDC 1060505-4533-2
NDC Item60505453302
Packaging28 CAPSULE in 1 BOTTLE (60505-4533-2)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004201

NDC 963304-042
NDC 1063304-042-01
NDC Item63304004201
Packaging100 CAPSULE in 1 BOTTLE (63304-042-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 63304004227

NDC 963304-042
NDC 1063304-042-27
NDC Item63304004227
Packaging28 CAPSULE in 1 BOTTLE (63304-042-27)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 69097038173

NDC 969097-381
NDC 1069097-381-73
NDC Item69097038173
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (69097-381-73)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla5mg;381
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 70710103101

NDC 970710-1031
NDC 1070710-1031-1
NDC Item70710103101
Packaging100 CAPSULE in 1 BOTTLE (70710-1031-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103107

NDC 970710-1031
NDC 1070710-1031-7
NDC Item70710103107
Packaging28 CAPSULE in 1 BOTTLE (70710-1031-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167701

NDC 970771-1677
NDC 1070771-1677-1
NDC Item70771167701
Packaging100 CAPSULE in 1 BOTTLE (70771-1677-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167707

NDC 970771-1677
NDC 1070771-1677-7
NDC Item70771167707
Packaging28 CAPSULE in 1 BOTTLE (70771-1677-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069748

NDC 976282-697
NDC 1076282-697-48
NDC Item76282069748
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (76282-697-48)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id792852
Imprint codeCipla5mg;381
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193601

NDC 90378-1936
NDC 100378-1936-01
NDC Item00378193601
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193628

NDC 90378-1936
NDC 100378-1936-28
NDC Item00378193628
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-28)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00480124228

NDC 90480-1242
NDC 100480-1242-28
NDC Item00480124228
Packaging28 CAPSULE in 1 BOTTLE (0480-1242-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;5mg
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 31722025801

NDC 931722-258
NDC 1031722-258-01
NDC Item31722025801
Packaging100 CAPSULE in 1 BOTTLE (31722-258-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 31722025828

NDC 931722-258
NDC 1031722-258-28
NDC Item31722025828
Packaging28 CAPSULE in 1 BOTTLE (31722-258-28)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 43598051101

NDC 943598-511
NDC 1043598-511-01
NDC Item43598051101
Packaging100 CAPSULE in 1 BOTTLE (43598-511-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051163

NDC 943598-511
NDC 1043598-511-63
NDC Item43598051163
Packaging28 CAPSULE in 1 BOTTLE (43598-511-63)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048401

NDC 947781-484
NDC 1047781-484-01
NDC Item47781048401
Packaging100 CAPSULE in 1 BOTTLE (47781-484-01)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 47781048428

NDC 947781-484
NDC 1047781-484-28
NDC Item47781048428
Packaging28 CAPSULE in 1 BOTTLE (47781-484-28)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034301

NDC 959651-343
NDC 1059651-343-01
NDC Item59651034301
Packaging100 CAPSULE in 1 BOTTLE (59651-343-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034307

NDC 959651-343
NDC 1059651-343-07
NDC Item59651034307
Packaging1 BLISTER PACK in 1 CARTON (59651-343-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 59651034328

NDC 959651-343
NDC 1059651-343-28
NDC Item59651034328
Packaging28 CAPSULE in 1 BOTTLE (59651-343-28)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 60505453301

NDC 960505-4533
NDC 1060505-4533-1
NDC Item60505453301
Packaging100 CAPSULE in 1 BOTTLE (60505-4533-1)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453302

NDC 960505-4533
NDC 1060505-4533-2
NDC Item60505453302
Packaging28 CAPSULE in 1 BOTTLE (60505-4533-2)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004201

NDC 963304-042
NDC 1063304-042-01
NDC Item63304004201
Packaging100 CAPSULE in 1 BOTTLE (63304-042-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 63304004227

NDC 963304-042
NDC 1063304-042-27
NDC Item63304004227
Packaging28 CAPSULE in 1 BOTTLE (63304-042-27)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 69097038173

NDC 969097-381
NDC 1069097-381-73
NDC Item69097038173
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (69097-381-73)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla5mg;381
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 70710103101

NDC 970710-1031
NDC 1070710-1031-1
NDC Item70710103101
Packaging100 CAPSULE in 1 BOTTLE (70710-1031-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103107

NDC 970710-1031
NDC 1070710-1031-7
NDC Item70710103107
Packaging28 CAPSULE in 1 BOTTLE (70710-1031-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167701

NDC 970771-1677
NDC 1070771-1677-1
NDC Item70771167701
Packaging100 CAPSULE in 1 BOTTLE (70771-1677-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167707

NDC 970771-1677
NDC 1070771-1677-7
NDC Item70771167707
Packaging28 CAPSULE in 1 BOTTLE (70771-1677-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069748

NDC 976282-697
NDC 1076282-697-48
NDC Item76282069748
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (76282-697-48)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id792852
Imprint codeCipla5mg;381
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193601

NDC 90378-1936
NDC 100378-1936-01
NDC Item00378193601
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00378193628

NDC 90378-1936
NDC 100378-1936-28
NDC Item00378193628
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1936-28)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 00480124228

NDC 90480-1242
NDC 100480-1242-28
NDC Item00480124228
Packaging28 CAPSULE in 1 BOTTLE (0480-1242-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;5mg
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 31722025801

NDC 931722-258
NDC 1031722-258-01
NDC Item31722025801
Packaging100 CAPSULE in 1 BOTTLE (31722-258-01)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 31722-258

NDC Item 31722025828

NDC 931722-258
NDC 1031722-258-28
NDC Item31722025828
Packaging28 CAPSULE in 1 BOTTLE (31722-258-28)
ANDAANDA212414
COLORTEXTwhite
ColorC48325 __
FDA SPL set id802288
Imprint codeH;L2
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 31722-258

NDC Item 43598051101

NDC 943598-511
NDC 1043598-511-01
NDC Item43598051101
Packaging100 CAPSULE in 1 BOTTLE (43598-511-01)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43598-511

NDC Item 43598051163

NDC 943598-511
NDC 1043598-511-63
NDC Item43598051163
Packaging28 CAPSULE in 1 BOTTLE (43598-511-63)
ANDAANDA209348
COLORTEXTWHITE(opaque white colored cap and body)
ColorC48325 __
FDA SPL set id727151
Imprint codeRDY;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048401

NDC 947781-484
NDC 1047781-484-01
NDC Item47781048401
Packaging100 CAPSULE in 1 BOTTLE (47781-484-01)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 47781-484

NDC Item 47781048428

NDC 947781-484
NDC 1047781-484-28
NDC Item47781048428
Packaging28 CAPSULE in 1 BOTTLE (47781-484-28)
ANDAANDA210480
COLORTEXTGREEN,YELLOW(light caramel)
ColorC48329;C48330 __
FDA SPL set id789803
Imprint codeLP;638
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-03
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 47781-484

NDC Item 59651034301

NDC 959651-343
NDC 1059651-343-01
NDC Item59651034301
Packaging100 CAPSULE in 1 BOTTLE (59651-343-01)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 59651-343

NDC Item 59651034307

NDC 959651-343
NDC 1059651-343-07
NDC Item59651034307
Packaging1 BLISTER PACK in 1 CARTON (59651-343-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 59651-343

NDC Item 59651034328

NDC 959651-343
NDC 1059651-343-28
NDC Item59651034328
Packaging28 CAPSULE in 1 BOTTLE (59651-343-28)
ANDAANDA213885
COLORTEXTWHITE(White Opaque Cap, White Opaque Body)
ColorC48325 __
FDA SPL set id717399
Imprint codeL;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 59651-343

NDC Item 60505453301

NDC 960505-4533
NDC 1060505-4533-1
NDC Item60505453301
Packaging100 CAPSULE in 1 BOTTLE (60505-4533-1)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 60505-4533

NDC Item 60505453302

NDC 960505-4533
NDC 1060505-4533-2
NDC Item60505453302
Packaging28 CAPSULE in 1 BOTTLE (60505-4533-2)
ANDAANDA211022
COLORTEXTWHITE(white opaque),WHITE(white opaque)
ColorC48325;C48325 __
FDA SPL set id794910
Imprint codeAPO;L5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 60505-4533

NDC Item 63304004201

NDC 963304-042
NDC 1063304-042-01
NDC Item63304004201
Packaging100 CAPSULE in 1 BOTTLE (63304-042-01)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
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NDC Item 63304004227

NDC 963304-042
NDC 1063304-042-27
NDC Item63304004227
Packaging28 CAPSULE in 1 BOTTLE (63304-042-27)
ANDAANDA211846
COLORTEXTWHITE,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;79
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 63304-042

NDC Item 69097038173

NDC 969097-381
NDC 1069097-381-73
NDC Item69097038173
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (69097-381-73)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id698711
Imprint codeCipla5mg;381
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 69097-381

NDC Item 70710103101

NDC 970710-1031
NDC 1070710-1031-1
NDC Item70710103101
Packaging100 CAPSULE in 1 BOTTLE (70710-1031-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
Related queriesProperties for NDC 9 70710-1031

NDC Item 70710103107

NDC 970710-1031
NDC 1070710-1031-7
NDC Item70710103107
Packaging28 CAPSULE in 1 BOTTLE (70710-1031-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id770365
Imprint code1031
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
Related queriesProperties for NDC 9 70710-1031

NDC Item 70771167701

NDC 970771-1677
NDC 1070771-1677-1
NDC Item70771167701
Packaging100 CAPSULE in 1 BOTTLE (70771-1677-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
Related queriesProperties for NDC 9 70771-1677

NDC Item 70771167707

NDC 970771-1677
NDC 1070771-1677-7
NDC Item70771167707
Packaging28 CAPSULE in 1 BOTTLE (70771-1677-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with white opaque body)
ColorC48325 __
FDA SPL set id800438
Imprint code1031
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
Related queriesProperties for NDC 9 70771-1677

NDC Item 76282069748

NDC 976282-697
NDC 1076282-697-48
NDC Item76282069748
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (76282-697-48)
ANDAANDA210435
COLORTEXTWHITE(printed in black-ink)
ColorC48325 __
FDA SPL set id792852
Imprint codeCipla5mg;381
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 76282-697