RxSearch

NDC properties for "lenalidomide 15 MG Oral Capsule" (RxCUI 643712)

About this data

The tables show NDC propoerties for lenalidomide 15 MG Oral Capsule with the RxCUI 643712

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 15 MG Oral Capsule (RxCUI 643712)

ANDAANDA201452
ANDAANDA209348
ANDAANDA210154
ANDAANDA210435
ANDAANDA210480
ANDAANDA211022
ANDAANDA211846
ANDAANDA212414
ANDAANDA213885
ANDAANDA213912
MMSL_CODEBD16977
MMSL_CODECD16977
RxCUI643712
SNOMEDCT840663005
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
VUID4025612
Prescribable Synonymlenalidomide 15 MG Oral Capsule
RXNAV_STRlenalidomide 15 MG Oral Capsule
RxNorm Namelenalidomide 15 MG Oral Capsule
Related queriesInteractions (for RxCUI 643712)



NDC Properties

NDC Item 00378194101

NDC 90378-1941
NDC 100378-1941-01
NDC Item00378194101
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 0378-1941

NDC Item 00378194121

NDC 90378-1941
NDC 100378-1941-21
NDC Item00378194121
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 0378-1941

NDC Item 00480124421

NDC 90480-1244
NDC 100480-1244-21
NDC Item00480124421
Packaging21 CAPSULE in 1 BOTTLE (0480-1244-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;15mg
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 0480-1244

NDC Item 31722026001

NDC 931722-260
NDC 1031722-260-01
NDC Item31722026001
Packaging100 CAPSULE in 1 BOTTLE (31722-260-01)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 31722-260

NDC Item 31722026021

NDC 931722-260
NDC 1031722-260-21
NDC Item31722026021
Packaging21 CAPSULE in 1 BOTTLE (31722-260-21)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 31722-260

NDC Item 43598051301

NDC 943598-513
NDC 1043598-513-01
NDC Item43598051301
Packaging100 CAPSULE in 1 BOTTLE (43598-513-01)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43598-513

NDC Item 43598051321

NDC 943598-513
NDC 1043598-513-21
NDC Item43598051321
Packaging21 CAPSULE in 1 BOTTLE (43598-513-21)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43598-513

NDC Item 47781048601

NDC 947781-486
NDC 1047781-486-01
NDC Item47781048601
Packaging100 CAPSULE in 1 BOTTLE (47781-486-01)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 47781-486

NDC Item 47781048677

NDC 947781-486
NDC 1047781-486-77
NDC Item47781048677
Packaging21 CAPSULE in 1 BOTTLE (47781-486-77)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 47781-486

NDC Item 59651034501

NDC 959651-345
NDC 1059651-345-01
NDC Item59651034501
Packaging100 CAPSULE in 1 BOTTLE (59651-345-01)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 59651-345

NDC Item 59651034507

NDC 959651-345
NDC 1059651-345-07
NDC Item59651034507
Packaging1 BLISTER PACK in 1 CARTON (59651-345-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 59651-345

NDC Item 59651034521

NDC 959651-345
NDC 1059651-345-21
NDC Item59651034521
Packaging21 CAPSULE in 1 BOTTLE (59651-345-21)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 59651-345

NDC Item 60505453501

NDC 960505-4535
NDC 1060505-4535-1
NDC Item60505453501
Packaging100 CAPSULE in 1 BOTTLE (60505-4535-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 60505-4535

NDC Item 60505453502

NDC 960505-4535
NDC 1060505-4535-2
NDC Item60505453502
Packaging21 CAPSULE in 1 BOTTLE (60505-4535-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 60505-4535

NDC Item 63304004401

NDC 963304-044
NDC 1063304-044-01
NDC Item63304004401
Packaging100 CAPSULE in 1 BOTTLE (63304-044-01)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 63304-044

NDC Item 63304004422

NDC 963304-044
NDC 1063304-044-22
NDC Item63304004422
Packaging21 CAPSULE in 1 BOTTLE (63304-044-22)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 63304-044

NDC Item 69097038381

NDC 969097-383
NDC 1069097-383-81
NDC Item69097038381
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-383-81)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id698711
Imprint codeCipla15mg;383
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 69097-383

NDC Item 70710103301

NDC 970710-1033
NDC 1070710-1033-1
NDC Item70710103301
Packaging100 CAPSULE in 1 BOTTLE (70710-1033-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 70710-1033

NDC Item 70710103308

NDC 970710-1033
NDC 1070710-1033-8
NDC Item70710103308
Packaging21 CAPSULE in 1 BOTTLE (70710-1033-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 70710-1033

NDC Item 70771167901

NDC 970771-1679
NDC 1070771-1679-1
NDC Item70771167901
Packaging100 CAPSULE in 1 BOTTLE (70771-1679-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 70771-1679

NDC Item 70771167908

NDC 970771-1679
NDC 1070771-1679-8
NDC Item70771167908
Packaging21 CAPSULE in 1 BOTTLE (70771-1679-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 70771-1679

NDC Item 76282069947

NDC 976282-699
NDC 1076282-699-47
NDC Item76282069947
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-699-47)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id792852
Imprint codeCipla15mg;383
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 76282-699

NDC Item 00378194101

NDC 90378-1941
NDC 100378-1941-01
NDC Item00378194101
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 0378-1941

NDC Item 00378194121

NDC 90378-1941
NDC 100378-1941-21
NDC Item00378194121
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 0378-1941

NDC Item 00480124421

NDC 90480-1244
NDC 100480-1244-21
NDC Item00480124421
Packaging21 CAPSULE in 1 BOTTLE (0480-1244-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;15mg
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 0480-1244

NDC Item 31722026001

NDC 931722-260
NDC 1031722-260-01
NDC Item31722026001
Packaging100 CAPSULE in 1 BOTTLE (31722-260-01)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 31722-260

NDC Item 31722026021

NDC 931722-260
NDC 1031722-260-21
NDC Item31722026021
Packaging21 CAPSULE in 1 BOTTLE (31722-260-21)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
Related queriesProperties for NDC 9 31722-260

NDC Item 43598051301

NDC 943598-513
NDC 1043598-513-01
NDC Item43598051301
Packaging100 CAPSULE in 1 BOTTLE (43598-513-01)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43598-513

NDC Item 43598051321

NDC 943598-513
NDC 1043598-513-21
NDC Item43598051321
Packaging21 CAPSULE in 1 BOTTLE (43598-513-21)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 43598-513

NDC Item 47781048601

NDC 947781-486
NDC 1047781-486-01
NDC Item47781048601
Packaging100 CAPSULE in 1 BOTTLE (47781-486-01)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 47781-486

NDC Item 47781048677

NDC 947781-486
NDC 1047781-486-77
NDC Item47781048677
Packaging21 CAPSULE in 1 BOTTLE (47781-486-77)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 47781-486

NDC Item 59651034501

NDC 959651-345
NDC 1059651-345-01
NDC Item59651034501
Packaging100 CAPSULE in 1 BOTTLE (59651-345-01)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 59651-345

NDC Item 59651034507

NDC 959651-345
NDC 1059651-345-07
NDC Item59651034507
Packaging1 BLISTER PACK in 1 CARTON (59651-345-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 59651-345

NDC Item 59651034521

NDC 959651-345
NDC 1059651-345-21
NDC Item59651034521
Packaging21 CAPSULE in 1 BOTTLE (59651-345-21)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 59651-345

NDC Item 60505453501

NDC 960505-4535
NDC 1060505-4535-1
NDC Item60505453501
Packaging100 CAPSULE in 1 BOTTLE (60505-4535-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 60505-4535

NDC Item 60505453502

NDC 960505-4535
NDC 1060505-4535-2
NDC Item60505453502
Packaging21 CAPSULE in 1 BOTTLE (60505-4535-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
Related queriesProperties for NDC 9 60505-4535

NDC Item 63304004401

NDC 963304-044
NDC 1063304-044-01
NDC Item63304004401
Packaging100 CAPSULE in 1 BOTTLE (63304-044-01)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 63304-044

NDC Item 63304004422

NDC 963304-044
NDC 1063304-044-22
NDC Item63304004422
Packaging21 CAPSULE in 1 BOTTLE (63304-044-22)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 63304-044

NDC Item 69097038381

NDC 969097-383
NDC 1069097-383-81
NDC Item69097038381
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-383-81)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id698711
Imprint codeCipla15mg;383
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 70710103301

NDC 970710-1033
NDC 1070710-1033-1
NDC Item70710103301
Packaging100 CAPSULE in 1 BOTTLE (70710-1033-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70710103308

NDC 970710-1033
NDC 1070710-1033-8
NDC Item70710103308
Packaging21 CAPSULE in 1 BOTTLE (70710-1033-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167901

NDC 970771-1679
NDC 1070771-1679-1
NDC Item70771167901
Packaging100 CAPSULE in 1 BOTTLE (70771-1679-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167908

NDC 970771-1679
NDC 1070771-1679-8
NDC Item70771167908
Packaging21 CAPSULE in 1 BOTTLE (70771-1679-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 76282069947

NDC 976282-699
NDC 1076282-699-47
NDC Item76282069947
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-699-47)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id792852
Imprint codeCipla15mg;383
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 00378194101

NDC 90378-1941
NDC 100378-1941-01
NDC Item00378194101
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194121

NDC 90378-1941
NDC 100378-1941-21
NDC Item00378194121
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124421

NDC 90480-1244
NDC 100480-1244-21
NDC Item00480124421
Packaging21 CAPSULE in 1 BOTTLE (0480-1244-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;15mg
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 31722026001

NDC 931722-260
NDC 1031722-260-01
NDC Item31722026001
Packaging100 CAPSULE in 1 BOTTLE (31722-260-01)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026021

NDC 931722-260
NDC 1031722-260-21
NDC Item31722026021
Packaging21 CAPSULE in 1 BOTTLE (31722-260-21)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051301

NDC 943598-513
NDC 1043598-513-01
NDC Item43598051301
Packaging100 CAPSULE in 1 BOTTLE (43598-513-01)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43598051321

NDC 943598-513
NDC 1043598-513-21
NDC Item43598051321
Packaging21 CAPSULE in 1 BOTTLE (43598-513-21)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 47781048601

NDC 947781-486
NDC 1047781-486-01
NDC Item47781048601
Packaging100 CAPSULE in 1 BOTTLE (47781-486-01)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 47781048677

NDC 947781-486
NDC 1047781-486-77
NDC Item47781048677
Packaging21 CAPSULE in 1 BOTTLE (47781-486-77)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 59651034501

NDC 959651-345
NDC 1059651-345-01
NDC Item59651034501
Packaging100 CAPSULE in 1 BOTTLE (59651-345-01)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034507

NDC 959651-345
NDC 1059651-345-07
NDC Item59651034507
Packaging1 BLISTER PACK in 1 CARTON (59651-345-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034521

NDC 959651-345
NDC 1059651-345-21
NDC Item59651034521
Packaging21 CAPSULE in 1 BOTTLE (59651-345-21)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453501

NDC 960505-4535
NDC 1060505-4535-1
NDC Item60505453501
Packaging100 CAPSULE in 1 BOTTLE (60505-4535-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 60505453502

NDC 960505-4535
NDC 1060505-4535-2
NDC Item60505453502
Packaging21 CAPSULE in 1 BOTTLE (60505-4535-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63304004401

NDC 963304-044
NDC 1063304-044-01
NDC Item63304004401
Packaging100 CAPSULE in 1 BOTTLE (63304-044-01)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004422

NDC 963304-044
NDC 1063304-044-22
NDC Item63304004422
Packaging21 CAPSULE in 1 BOTTLE (63304-044-22)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038381

NDC 969097-383
NDC 1069097-383-81
NDC Item69097038381
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-383-81)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id698711
Imprint codeCipla15mg;383
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 70710103301

NDC 970710-1033
NDC 1070710-1033-1
NDC Item70710103301
Packaging100 CAPSULE in 1 BOTTLE (70710-1033-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70710103308

NDC 970710-1033
NDC 1070710-1033-8
NDC Item70710103308
Packaging21 CAPSULE in 1 BOTTLE (70710-1033-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167901

NDC 970771-1679
NDC 1070771-1679-1
NDC Item70771167901
Packaging100 CAPSULE in 1 BOTTLE (70771-1679-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167908

NDC 970771-1679
NDC 1070771-1679-8
NDC Item70771167908
Packaging21 CAPSULE in 1 BOTTLE (70771-1679-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 76282069947

NDC 976282-699
NDC 1076282-699-47
NDC Item76282069947
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-699-47)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id792852
Imprint codeCipla15mg;383
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 00378194101

NDC 90378-1941
NDC 100378-1941-01
NDC Item00378194101
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194121

NDC 90378-1941
NDC 100378-1941-21
NDC Item00378194121
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124421

NDC 90480-1244
NDC 100480-1244-21
NDC Item00480124421
Packaging21 CAPSULE in 1 BOTTLE (0480-1244-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;15mg
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 31722026001

NDC 931722-260
NDC 1031722-260-01
NDC Item31722026001
Packaging100 CAPSULE in 1 BOTTLE (31722-260-01)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026021

NDC 931722-260
NDC 1031722-260-21
NDC Item31722026021
Packaging21 CAPSULE in 1 BOTTLE (31722-260-21)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051301

NDC 943598-513
NDC 1043598-513-01
NDC Item43598051301
Packaging100 CAPSULE in 1 BOTTLE (43598-513-01)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43598051321

NDC 943598-513
NDC 1043598-513-21
NDC Item43598051321
Packaging21 CAPSULE in 1 BOTTLE (43598-513-21)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 47781048601

NDC 947781-486
NDC 1047781-486-01
NDC Item47781048601
Packaging100 CAPSULE in 1 BOTTLE (47781-486-01)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 47781048677

NDC 947781-486
NDC 1047781-486-77
NDC Item47781048677
Packaging21 CAPSULE in 1 BOTTLE (47781-486-77)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 59651034501

NDC 959651-345
NDC 1059651-345-01
NDC Item59651034501
Packaging100 CAPSULE in 1 BOTTLE (59651-345-01)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034507

NDC 959651-345
NDC 1059651-345-07
NDC Item59651034507
Packaging1 BLISTER PACK in 1 CARTON (59651-345-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034521

NDC 959651-345
NDC 1059651-345-21
NDC Item59651034521
Packaging21 CAPSULE in 1 BOTTLE (59651-345-21)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453501

NDC 960505-4535
NDC 1060505-4535-1
NDC Item60505453501
Packaging100 CAPSULE in 1 BOTTLE (60505-4535-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 60505453502

NDC 960505-4535
NDC 1060505-4535-2
NDC Item60505453502
Packaging21 CAPSULE in 1 BOTTLE (60505-4535-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63304004401

NDC 963304-044
NDC 1063304-044-01
NDC Item63304004401
Packaging100 CAPSULE in 1 BOTTLE (63304-044-01)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004422

NDC 963304-044
NDC 1063304-044-22
NDC Item63304004422
Packaging21 CAPSULE in 1 BOTTLE (63304-044-22)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038381

NDC 969097-383
NDC 1069097-383-81
NDC Item69097038381
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-383-81)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id698711
Imprint codeCipla15mg;383
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 70710103301

NDC 970710-1033
NDC 1070710-1033-1
NDC Item70710103301
Packaging100 CAPSULE in 1 BOTTLE (70710-1033-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70710103308

NDC 970710-1033
NDC 1070710-1033-8
NDC Item70710103308
Packaging21 CAPSULE in 1 BOTTLE (70710-1033-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167901

NDC 970771-1679
NDC 1070771-1679-1
NDC Item70771167901
Packaging100 CAPSULE in 1 BOTTLE (70771-1679-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167908

NDC 970771-1679
NDC 1070771-1679-8
NDC Item70771167908
Packaging21 CAPSULE in 1 BOTTLE (70771-1679-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 76282069947

NDC 976282-699
NDC 1076282-699-47
NDC Item76282069947
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-699-47)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id792852
Imprint codeCipla15mg;383
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 00378194101

NDC 90378-1941
NDC 100378-1941-01
NDC Item00378194101
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194121

NDC 90378-1941
NDC 100378-1941-21
NDC Item00378194121
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124421

NDC 90480-1244
NDC 100480-1244-21
NDC Item00480124421
Packaging21 CAPSULE in 1 BOTTLE (0480-1244-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;15mg
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 31722026001

NDC 931722-260
NDC 1031722-260-01
NDC Item31722026001
Packaging100 CAPSULE in 1 BOTTLE (31722-260-01)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026021

NDC 931722-260
NDC 1031722-260-21
NDC Item31722026021
Packaging21 CAPSULE in 1 BOTTLE (31722-260-21)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051301

NDC 943598-513
NDC 1043598-513-01
NDC Item43598051301
Packaging100 CAPSULE in 1 BOTTLE (43598-513-01)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43598051321

NDC 943598-513
NDC 1043598-513-21
NDC Item43598051321
Packaging21 CAPSULE in 1 BOTTLE (43598-513-21)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 47781048601

NDC 947781-486
NDC 1047781-486-01
NDC Item47781048601
Packaging100 CAPSULE in 1 BOTTLE (47781-486-01)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 47781048677

NDC 947781-486
NDC 1047781-486-77
NDC Item47781048677
Packaging21 CAPSULE in 1 BOTTLE (47781-486-77)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 59651034501

NDC 959651-345
NDC 1059651-345-01
NDC Item59651034501
Packaging100 CAPSULE in 1 BOTTLE (59651-345-01)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034507

NDC 959651-345
NDC 1059651-345-07
NDC Item59651034507
Packaging1 BLISTER PACK in 1 CARTON (59651-345-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034521

NDC 959651-345
NDC 1059651-345-21
NDC Item59651034521
Packaging21 CAPSULE in 1 BOTTLE (59651-345-21)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453501

NDC 960505-4535
NDC 1060505-4535-1
NDC Item60505453501
Packaging100 CAPSULE in 1 BOTTLE (60505-4535-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 60505453502

NDC 960505-4535
NDC 1060505-4535-2
NDC Item60505453502
Packaging21 CAPSULE in 1 BOTTLE (60505-4535-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63304004401

NDC 963304-044
NDC 1063304-044-01
NDC Item63304004401
Packaging100 CAPSULE in 1 BOTTLE (63304-044-01)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004422

NDC 963304-044
NDC 1063304-044-22
NDC Item63304004422
Packaging21 CAPSULE in 1 BOTTLE (63304-044-22)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038381

NDC 969097-383
NDC 1069097-383-81
NDC Item69097038381
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-383-81)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id698711
Imprint codeCipla15mg;383
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 70710103301

NDC 970710-1033
NDC 1070710-1033-1
NDC Item70710103301
Packaging100 CAPSULE in 1 BOTTLE (70710-1033-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70710103308

NDC 970710-1033
NDC 1070710-1033-8
NDC Item70710103308
Packaging21 CAPSULE in 1 BOTTLE (70710-1033-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167901

NDC 970771-1679
NDC 1070771-1679-1
NDC Item70771167901
Packaging100 CAPSULE in 1 BOTTLE (70771-1679-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167908

NDC 970771-1679
NDC 1070771-1679-8
NDC Item70771167908
Packaging21 CAPSULE in 1 BOTTLE (70771-1679-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 76282069947

NDC 976282-699
NDC 1076282-699-47
NDC Item76282069947
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-699-47)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id792852
Imprint codeCipla15mg;383
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 00378194101

NDC 90378-1941
NDC 100378-1941-01
NDC Item00378194101
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194121

NDC 90378-1941
NDC 100378-1941-21
NDC Item00378194121
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124421

NDC 90480-1244
NDC 100480-1244-21
NDC Item00480124421
Packaging21 CAPSULE in 1 BOTTLE (0480-1244-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;15mg
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 31722026001

NDC 931722-260
NDC 1031722-260-01
NDC Item31722026001
Packaging100 CAPSULE in 1 BOTTLE (31722-260-01)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026021

NDC 931722-260
NDC 1031722-260-21
NDC Item31722026021
Packaging21 CAPSULE in 1 BOTTLE (31722-260-21)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051301

NDC 943598-513
NDC 1043598-513-01
NDC Item43598051301
Packaging100 CAPSULE in 1 BOTTLE (43598-513-01)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43598051321

NDC 943598-513
NDC 1043598-513-21
NDC Item43598051321
Packaging21 CAPSULE in 1 BOTTLE (43598-513-21)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 47781048601

NDC 947781-486
NDC 1047781-486-01
NDC Item47781048601
Packaging100 CAPSULE in 1 BOTTLE (47781-486-01)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 47781048677

NDC 947781-486
NDC 1047781-486-77
NDC Item47781048677
Packaging21 CAPSULE in 1 BOTTLE (47781-486-77)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 59651034501

NDC 959651-345
NDC 1059651-345-01
NDC Item59651034501
Packaging100 CAPSULE in 1 BOTTLE (59651-345-01)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034507

NDC 959651-345
NDC 1059651-345-07
NDC Item59651034507
Packaging1 BLISTER PACK in 1 CARTON (59651-345-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034521

NDC 959651-345
NDC 1059651-345-21
NDC Item59651034521
Packaging21 CAPSULE in 1 BOTTLE (59651-345-21)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453501

NDC 960505-4535
NDC 1060505-4535-1
NDC Item60505453501
Packaging100 CAPSULE in 1 BOTTLE (60505-4535-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 60505453502

NDC 960505-4535
NDC 1060505-4535-2
NDC Item60505453502
Packaging21 CAPSULE in 1 BOTTLE (60505-4535-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63304004401

NDC 963304-044
NDC 1063304-044-01
NDC Item63304004401
Packaging100 CAPSULE in 1 BOTTLE (63304-044-01)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004422

NDC 963304-044
NDC 1063304-044-22
NDC Item63304004422
Packaging21 CAPSULE in 1 BOTTLE (63304-044-22)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038381

NDC 969097-383
NDC 1069097-383-81
NDC Item69097038381
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-383-81)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id698711
Imprint codeCipla15mg;383
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 70710103301

NDC 970710-1033
NDC 1070710-1033-1
NDC Item70710103301
Packaging100 CAPSULE in 1 BOTTLE (70710-1033-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70710103308

NDC 970710-1033
NDC 1070710-1033-8
NDC Item70710103308
Packaging21 CAPSULE in 1 BOTTLE (70710-1033-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167901

NDC 970771-1679
NDC 1070771-1679-1
NDC Item70771167901
Packaging100 CAPSULE in 1 BOTTLE (70771-1679-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167908

NDC 970771-1679
NDC 1070771-1679-8
NDC Item70771167908
Packaging21 CAPSULE in 1 BOTTLE (70771-1679-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 76282069947

NDC 976282-699
NDC 1076282-699-47
NDC Item76282069947
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-699-47)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id792852
Imprint codeCipla15mg;383
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 00378194101

NDC 90378-1941
NDC 100378-1941-01
NDC Item00378194101
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194121

NDC 90378-1941
NDC 100378-1941-21
NDC Item00378194121
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124421

NDC 90480-1244
NDC 100480-1244-21
NDC Item00480124421
Packaging21 CAPSULE in 1 BOTTLE (0480-1244-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;15mg
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 31722026001

NDC 931722-260
NDC 1031722-260-01
NDC Item31722026001
Packaging100 CAPSULE in 1 BOTTLE (31722-260-01)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026021

NDC 931722-260
NDC 1031722-260-21
NDC Item31722026021
Packaging21 CAPSULE in 1 BOTTLE (31722-260-21)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051301

NDC 943598-513
NDC 1043598-513-01
NDC Item43598051301
Packaging100 CAPSULE in 1 BOTTLE (43598-513-01)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43598051321

NDC 943598-513
NDC 1043598-513-21
NDC Item43598051321
Packaging21 CAPSULE in 1 BOTTLE (43598-513-21)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 47781048601

NDC 947781-486
NDC 1047781-486-01
NDC Item47781048601
Packaging100 CAPSULE in 1 BOTTLE (47781-486-01)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 47781048677

NDC 947781-486
NDC 1047781-486-77
NDC Item47781048677
Packaging21 CAPSULE in 1 BOTTLE (47781-486-77)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 59651034501

NDC 959651-345
NDC 1059651-345-01
NDC Item59651034501
Packaging100 CAPSULE in 1 BOTTLE (59651-345-01)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034507

NDC 959651-345
NDC 1059651-345-07
NDC Item59651034507
Packaging1 BLISTER PACK in 1 CARTON (59651-345-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034521

NDC 959651-345
NDC 1059651-345-21
NDC Item59651034521
Packaging21 CAPSULE in 1 BOTTLE (59651-345-21)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453501

NDC 960505-4535
NDC 1060505-4535-1
NDC Item60505453501
Packaging100 CAPSULE in 1 BOTTLE (60505-4535-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 60505453502

NDC 960505-4535
NDC 1060505-4535-2
NDC Item60505453502
Packaging21 CAPSULE in 1 BOTTLE (60505-4535-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63304004401

NDC 963304-044
NDC 1063304-044-01
NDC Item63304004401
Packaging100 CAPSULE in 1 BOTTLE (63304-044-01)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004422

NDC 963304-044
NDC 1063304-044-22
NDC Item63304004422
Packaging21 CAPSULE in 1 BOTTLE (63304-044-22)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038381

NDC 969097-383
NDC 1069097-383-81
NDC Item69097038381
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-383-81)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id698711
Imprint codeCipla15mg;383
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 70710103301

NDC 970710-1033
NDC 1070710-1033-1
NDC Item70710103301
Packaging100 CAPSULE in 1 BOTTLE (70710-1033-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70710103308

NDC 970710-1033
NDC 1070710-1033-8
NDC Item70710103308
Packaging21 CAPSULE in 1 BOTTLE (70710-1033-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167901

NDC 970771-1679
NDC 1070771-1679-1
NDC Item70771167901
Packaging100 CAPSULE in 1 BOTTLE (70771-1679-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167908

NDC 970771-1679
NDC 1070771-1679-8
NDC Item70771167908
Packaging21 CAPSULE in 1 BOTTLE (70771-1679-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 76282069947

NDC 976282-699
NDC 1076282-699-47
NDC Item76282069947
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-699-47)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id792852
Imprint codeCipla15mg;383
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 00378194101

NDC 90378-1941
NDC 100378-1941-01
NDC Item00378194101
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194121

NDC 90378-1941
NDC 100378-1941-21
NDC Item00378194121
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124421

NDC 90480-1244
NDC 100480-1244-21
NDC Item00480124421
Packaging21 CAPSULE in 1 BOTTLE (0480-1244-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;15mg
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 31722026001

NDC 931722-260
NDC 1031722-260-01
NDC Item31722026001
Packaging100 CAPSULE in 1 BOTTLE (31722-260-01)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026021

NDC 931722-260
NDC 1031722-260-21
NDC Item31722026021
Packaging21 CAPSULE in 1 BOTTLE (31722-260-21)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051301

NDC 943598-513
NDC 1043598-513-01
NDC Item43598051301
Packaging100 CAPSULE in 1 BOTTLE (43598-513-01)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43598051321

NDC 943598-513
NDC 1043598-513-21
NDC Item43598051321
Packaging21 CAPSULE in 1 BOTTLE (43598-513-21)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 47781048601

NDC 947781-486
NDC 1047781-486-01
NDC Item47781048601
Packaging100 CAPSULE in 1 BOTTLE (47781-486-01)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 47781048677

NDC 947781-486
NDC 1047781-486-77
NDC Item47781048677
Packaging21 CAPSULE in 1 BOTTLE (47781-486-77)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 59651034501

NDC 959651-345
NDC 1059651-345-01
NDC Item59651034501
Packaging100 CAPSULE in 1 BOTTLE (59651-345-01)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034507

NDC 959651-345
NDC 1059651-345-07
NDC Item59651034507
Packaging1 BLISTER PACK in 1 CARTON (59651-345-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034521

NDC 959651-345
NDC 1059651-345-21
NDC Item59651034521
Packaging21 CAPSULE in 1 BOTTLE (59651-345-21)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453501

NDC 960505-4535
NDC 1060505-4535-1
NDC Item60505453501
Packaging100 CAPSULE in 1 BOTTLE (60505-4535-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 60505453502

NDC 960505-4535
NDC 1060505-4535-2
NDC Item60505453502
Packaging21 CAPSULE in 1 BOTTLE (60505-4535-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63304004401

NDC 963304-044
NDC 1063304-044-01
NDC Item63304004401
Packaging100 CAPSULE in 1 BOTTLE (63304-044-01)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004422

NDC 963304-044
NDC 1063304-044-22
NDC Item63304004422
Packaging21 CAPSULE in 1 BOTTLE (63304-044-22)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038381

NDC 969097-383
NDC 1069097-383-81
NDC Item69097038381
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-383-81)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id698711
Imprint codeCipla15mg;383
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 70710103301

NDC 970710-1033
NDC 1070710-1033-1
NDC Item70710103301
Packaging100 CAPSULE in 1 BOTTLE (70710-1033-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70710103308

NDC 970710-1033
NDC 1070710-1033-8
NDC Item70710103308
Packaging21 CAPSULE in 1 BOTTLE (70710-1033-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167901

NDC 970771-1679
NDC 1070771-1679-1
NDC Item70771167901
Packaging100 CAPSULE in 1 BOTTLE (70771-1679-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167908

NDC 970771-1679
NDC 1070771-1679-8
NDC Item70771167908
Packaging21 CAPSULE in 1 BOTTLE (70771-1679-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 76282069947

NDC 976282-699
NDC 1076282-699-47
NDC Item76282069947
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-699-47)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id792852
Imprint codeCipla15mg;383
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 00378194101

NDC 90378-1941
NDC 100378-1941-01
NDC Item00378194101
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194121

NDC 90378-1941
NDC 100378-1941-21
NDC Item00378194121
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124421

NDC 90480-1244
NDC 100480-1244-21
NDC Item00480124421
Packaging21 CAPSULE in 1 BOTTLE (0480-1244-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;15mg
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 31722026001

NDC 931722-260
NDC 1031722-260-01
NDC Item31722026001
Packaging100 CAPSULE in 1 BOTTLE (31722-260-01)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026021

NDC 931722-260
NDC 1031722-260-21
NDC Item31722026021
Packaging21 CAPSULE in 1 BOTTLE (31722-260-21)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051301

NDC 943598-513
NDC 1043598-513-01
NDC Item43598051301
Packaging100 CAPSULE in 1 BOTTLE (43598-513-01)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43598051321

NDC 943598-513
NDC 1043598-513-21
NDC Item43598051321
Packaging21 CAPSULE in 1 BOTTLE (43598-513-21)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 47781048601

NDC 947781-486
NDC 1047781-486-01
NDC Item47781048601
Packaging100 CAPSULE in 1 BOTTLE (47781-486-01)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 47781048677

NDC 947781-486
NDC 1047781-486-77
NDC Item47781048677
Packaging21 CAPSULE in 1 BOTTLE (47781-486-77)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 59651034501

NDC 959651-345
NDC 1059651-345-01
NDC Item59651034501
Packaging100 CAPSULE in 1 BOTTLE (59651-345-01)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034507

NDC 959651-345
NDC 1059651-345-07
NDC Item59651034507
Packaging1 BLISTER PACK in 1 CARTON (59651-345-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034521

NDC 959651-345
NDC 1059651-345-21
NDC Item59651034521
Packaging21 CAPSULE in 1 BOTTLE (59651-345-21)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453501

NDC 960505-4535
NDC 1060505-4535-1
NDC Item60505453501
Packaging100 CAPSULE in 1 BOTTLE (60505-4535-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 60505453502

NDC 960505-4535
NDC 1060505-4535-2
NDC Item60505453502
Packaging21 CAPSULE in 1 BOTTLE (60505-4535-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63304004401

NDC 963304-044
NDC 1063304-044-01
NDC Item63304004401
Packaging100 CAPSULE in 1 BOTTLE (63304-044-01)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004422

NDC 963304-044
NDC 1063304-044-22
NDC Item63304004422
Packaging21 CAPSULE in 1 BOTTLE (63304-044-22)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038381

NDC 969097-383
NDC 1069097-383-81
NDC Item69097038381
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-383-81)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id698711
Imprint codeCipla15mg;383
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 70710103301

NDC 970710-1033
NDC 1070710-1033-1
NDC Item70710103301
Packaging100 CAPSULE in 1 BOTTLE (70710-1033-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70710103308

NDC 970710-1033
NDC 1070710-1033-8
NDC Item70710103308
Packaging21 CAPSULE in 1 BOTTLE (70710-1033-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167901

NDC 970771-1679
NDC 1070771-1679-1
NDC Item70771167901
Packaging100 CAPSULE in 1 BOTTLE (70771-1679-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167908

NDC 970771-1679
NDC 1070771-1679-8
NDC Item70771167908
Packaging21 CAPSULE in 1 BOTTLE (70771-1679-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 76282069947

NDC 976282-699
NDC 1076282-699-47
NDC Item76282069947
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-699-47)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id792852
Imprint codeCipla15mg;383
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 00378194101

NDC 90378-1941
NDC 100378-1941-01
NDC Item00378194101
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194121

NDC 90378-1941
NDC 100378-1941-21
NDC Item00378194121
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124421

NDC 90480-1244
NDC 100480-1244-21
NDC Item00480124421
Packaging21 CAPSULE in 1 BOTTLE (0480-1244-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;15mg
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 31722026001

NDC 931722-260
NDC 1031722-260-01
NDC Item31722026001
Packaging100 CAPSULE in 1 BOTTLE (31722-260-01)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026021

NDC 931722-260
NDC 1031722-260-21
NDC Item31722026021
Packaging21 CAPSULE in 1 BOTTLE (31722-260-21)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051301

NDC 943598-513
NDC 1043598-513-01
NDC Item43598051301
Packaging100 CAPSULE in 1 BOTTLE (43598-513-01)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43598051321

NDC 943598-513
NDC 1043598-513-21
NDC Item43598051321
Packaging21 CAPSULE in 1 BOTTLE (43598-513-21)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 47781048601

NDC 947781-486
NDC 1047781-486-01
NDC Item47781048601
Packaging100 CAPSULE in 1 BOTTLE (47781-486-01)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 47781048677

NDC 947781-486
NDC 1047781-486-77
NDC Item47781048677
Packaging21 CAPSULE in 1 BOTTLE (47781-486-77)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 59651034501

NDC 959651-345
NDC 1059651-345-01
NDC Item59651034501
Packaging100 CAPSULE in 1 BOTTLE (59651-345-01)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034507

NDC 959651-345
NDC 1059651-345-07
NDC Item59651034507
Packaging1 BLISTER PACK in 1 CARTON (59651-345-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034521

NDC 959651-345
NDC 1059651-345-21
NDC Item59651034521
Packaging21 CAPSULE in 1 BOTTLE (59651-345-21)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453501

NDC 960505-4535
NDC 1060505-4535-1
NDC Item60505453501
Packaging100 CAPSULE in 1 BOTTLE (60505-4535-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 60505453502

NDC 960505-4535
NDC 1060505-4535-2
NDC Item60505453502
Packaging21 CAPSULE in 1 BOTTLE (60505-4535-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63304004401

NDC 963304-044
NDC 1063304-044-01
NDC Item63304004401
Packaging100 CAPSULE in 1 BOTTLE (63304-044-01)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004422

NDC 963304-044
NDC 1063304-044-22
NDC Item63304004422
Packaging21 CAPSULE in 1 BOTTLE (63304-044-22)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038381

NDC 969097-383
NDC 1069097-383-81
NDC Item69097038381
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-383-81)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id698711
Imprint codeCipla15mg;383
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 70710103301

NDC 970710-1033
NDC 1070710-1033-1
NDC Item70710103301
Packaging100 CAPSULE in 1 BOTTLE (70710-1033-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70710103308

NDC 970710-1033
NDC 1070710-1033-8
NDC Item70710103308
Packaging21 CAPSULE in 1 BOTTLE (70710-1033-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167901

NDC 970771-1679
NDC 1070771-1679-1
NDC Item70771167901
Packaging100 CAPSULE in 1 BOTTLE (70771-1679-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167908

NDC 970771-1679
NDC 1070771-1679-8
NDC Item70771167908
Packaging21 CAPSULE in 1 BOTTLE (70771-1679-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 76282069947

NDC 976282-699
NDC 1076282-699-47
NDC Item76282069947
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-699-47)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id792852
Imprint codeCipla15mg;383
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 00378194101

NDC 90378-1941
NDC 100378-1941-01
NDC Item00378194101
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194121

NDC 90378-1941
NDC 100378-1941-21
NDC Item00378194121
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124421

NDC 90480-1244
NDC 100480-1244-21
NDC Item00480124421
Packaging21 CAPSULE in 1 BOTTLE (0480-1244-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;15mg
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 31722026001

NDC 931722-260
NDC 1031722-260-01
NDC Item31722026001
Packaging100 CAPSULE in 1 BOTTLE (31722-260-01)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026021

NDC 931722-260
NDC 1031722-260-21
NDC Item31722026021
Packaging21 CAPSULE in 1 BOTTLE (31722-260-21)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051301

NDC 943598-513
NDC 1043598-513-01
NDC Item43598051301
Packaging100 CAPSULE in 1 BOTTLE (43598-513-01)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43598051321

NDC 943598-513
NDC 1043598-513-21
NDC Item43598051321
Packaging21 CAPSULE in 1 BOTTLE (43598-513-21)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 47781048601

NDC 947781-486
NDC 1047781-486-01
NDC Item47781048601
Packaging100 CAPSULE in 1 BOTTLE (47781-486-01)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 47781048677

NDC 947781-486
NDC 1047781-486-77
NDC Item47781048677
Packaging21 CAPSULE in 1 BOTTLE (47781-486-77)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 59651034501

NDC 959651-345
NDC 1059651-345-01
NDC Item59651034501
Packaging100 CAPSULE in 1 BOTTLE (59651-345-01)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034507

NDC 959651-345
NDC 1059651-345-07
NDC Item59651034507
Packaging1 BLISTER PACK in 1 CARTON (59651-345-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034521

NDC 959651-345
NDC 1059651-345-21
NDC Item59651034521
Packaging21 CAPSULE in 1 BOTTLE (59651-345-21)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453501

NDC 960505-4535
NDC 1060505-4535-1
NDC Item60505453501
Packaging100 CAPSULE in 1 BOTTLE (60505-4535-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 60505453502

NDC 960505-4535
NDC 1060505-4535-2
NDC Item60505453502
Packaging21 CAPSULE in 1 BOTTLE (60505-4535-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63304004401

NDC 963304-044
NDC 1063304-044-01
NDC Item63304004401
Packaging100 CAPSULE in 1 BOTTLE (63304-044-01)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004422

NDC 963304-044
NDC 1063304-044-22
NDC Item63304004422
Packaging21 CAPSULE in 1 BOTTLE (63304-044-22)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038381

NDC 969097-383
NDC 1069097-383-81
NDC Item69097038381
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-383-81)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id698711
Imprint codeCipla15mg;383
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 70710103301

NDC 970710-1033
NDC 1070710-1033-1
NDC Item70710103301
Packaging100 CAPSULE in 1 BOTTLE (70710-1033-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70710103308

NDC 970710-1033
NDC 1070710-1033-8
NDC Item70710103308
Packaging21 CAPSULE in 1 BOTTLE (70710-1033-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167901

NDC 970771-1679
NDC 1070771-1679-1
NDC Item70771167901
Packaging100 CAPSULE in 1 BOTTLE (70771-1679-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167908

NDC 970771-1679
NDC 1070771-1679-8
NDC Item70771167908
Packaging21 CAPSULE in 1 BOTTLE (70771-1679-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 76282069947

NDC 976282-699
NDC 1076282-699-47
NDC Item76282069947
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-699-47)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id792852
Imprint codeCipla15mg;383
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 00378194101

NDC 90378-1941
NDC 100378-1941-01
NDC Item00378194101
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194121

NDC 90378-1941
NDC 100378-1941-21
NDC Item00378194121
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124421

NDC 90480-1244
NDC 100480-1244-21
NDC Item00480124421
Packaging21 CAPSULE in 1 BOTTLE (0480-1244-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;15mg
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 31722026001

NDC 931722-260
NDC 1031722-260-01
NDC Item31722026001
Packaging100 CAPSULE in 1 BOTTLE (31722-260-01)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026021

NDC 931722-260
NDC 1031722-260-21
NDC Item31722026021
Packaging21 CAPSULE in 1 BOTTLE (31722-260-21)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051301

NDC 943598-513
NDC 1043598-513-01
NDC Item43598051301
Packaging100 CAPSULE in 1 BOTTLE (43598-513-01)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43598051321

NDC 943598-513
NDC 1043598-513-21
NDC Item43598051321
Packaging21 CAPSULE in 1 BOTTLE (43598-513-21)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 47781048601

NDC 947781-486
NDC 1047781-486-01
NDC Item47781048601
Packaging100 CAPSULE in 1 BOTTLE (47781-486-01)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 47781048677

NDC 947781-486
NDC 1047781-486-77
NDC Item47781048677
Packaging21 CAPSULE in 1 BOTTLE (47781-486-77)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 59651034501

NDC 959651-345
NDC 1059651-345-01
NDC Item59651034501
Packaging100 CAPSULE in 1 BOTTLE (59651-345-01)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034507

NDC 959651-345
NDC 1059651-345-07
NDC Item59651034507
Packaging1 BLISTER PACK in 1 CARTON (59651-345-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034521

NDC 959651-345
NDC 1059651-345-21
NDC Item59651034521
Packaging21 CAPSULE in 1 BOTTLE (59651-345-21)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453501

NDC 960505-4535
NDC 1060505-4535-1
NDC Item60505453501
Packaging100 CAPSULE in 1 BOTTLE (60505-4535-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 60505453502

NDC 960505-4535
NDC 1060505-4535-2
NDC Item60505453502
Packaging21 CAPSULE in 1 BOTTLE (60505-4535-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63304004401

NDC 963304-044
NDC 1063304-044-01
NDC Item63304004401
Packaging100 CAPSULE in 1 BOTTLE (63304-044-01)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004422

NDC 963304-044
NDC 1063304-044-22
NDC Item63304004422
Packaging21 CAPSULE in 1 BOTTLE (63304-044-22)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038381

NDC 969097-383
NDC 1069097-383-81
NDC Item69097038381
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-383-81)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id698711
Imprint codeCipla15mg;383
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 70710103301

NDC 970710-1033
NDC 1070710-1033-1
NDC Item70710103301
Packaging100 CAPSULE in 1 BOTTLE (70710-1033-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70710103308

NDC 970710-1033
NDC 1070710-1033-8
NDC Item70710103308
Packaging21 CAPSULE in 1 BOTTLE (70710-1033-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167901

NDC 970771-1679
NDC 1070771-1679-1
NDC Item70771167901
Packaging100 CAPSULE in 1 BOTTLE (70771-1679-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167908

NDC 970771-1679
NDC 1070771-1679-8
NDC Item70771167908
Packaging21 CAPSULE in 1 BOTTLE (70771-1679-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 76282069947

NDC 976282-699
NDC 1076282-699-47
NDC Item76282069947
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-699-47)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id792852
Imprint codeCipla15mg;383
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 00378194101

NDC 90378-1941
NDC 100378-1941-01
NDC Item00378194101
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194121

NDC 90378-1941
NDC 100378-1941-21
NDC Item00378194121
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124421

NDC 90480-1244
NDC 100480-1244-21
NDC Item00480124421
Packaging21 CAPSULE in 1 BOTTLE (0480-1244-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;15mg
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 31722026001

NDC 931722-260
NDC 1031722-260-01
NDC Item31722026001
Packaging100 CAPSULE in 1 BOTTLE (31722-260-01)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026021

NDC 931722-260
NDC 1031722-260-21
NDC Item31722026021
Packaging21 CAPSULE in 1 BOTTLE (31722-260-21)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051301

NDC 943598-513
NDC 1043598-513-01
NDC Item43598051301
Packaging100 CAPSULE in 1 BOTTLE (43598-513-01)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43598051321

NDC 943598-513
NDC 1043598-513-21
NDC Item43598051321
Packaging21 CAPSULE in 1 BOTTLE (43598-513-21)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 47781048601

NDC 947781-486
NDC 1047781-486-01
NDC Item47781048601
Packaging100 CAPSULE in 1 BOTTLE (47781-486-01)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 47781048677

NDC 947781-486
NDC 1047781-486-77
NDC Item47781048677
Packaging21 CAPSULE in 1 BOTTLE (47781-486-77)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 59651034501

NDC 959651-345
NDC 1059651-345-01
NDC Item59651034501
Packaging100 CAPSULE in 1 BOTTLE (59651-345-01)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034507

NDC 959651-345
NDC 1059651-345-07
NDC Item59651034507
Packaging1 BLISTER PACK in 1 CARTON (59651-345-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034521

NDC 959651-345
NDC 1059651-345-21
NDC Item59651034521
Packaging21 CAPSULE in 1 BOTTLE (59651-345-21)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453501

NDC 960505-4535
NDC 1060505-4535-1
NDC Item60505453501
Packaging100 CAPSULE in 1 BOTTLE (60505-4535-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 60505453502

NDC 960505-4535
NDC 1060505-4535-2
NDC Item60505453502
Packaging21 CAPSULE in 1 BOTTLE (60505-4535-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63304004401

NDC 963304-044
NDC 1063304-044-01
NDC Item63304004401
Packaging100 CAPSULE in 1 BOTTLE (63304-044-01)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004422

NDC 963304-044
NDC 1063304-044-22
NDC Item63304004422
Packaging21 CAPSULE in 1 BOTTLE (63304-044-22)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038381

NDC 969097-383
NDC 1069097-383-81
NDC Item69097038381
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-383-81)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id698711
Imprint codeCipla15mg;383
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 70710103301

NDC 970710-1033
NDC 1070710-1033-1
NDC Item70710103301
Packaging100 CAPSULE in 1 BOTTLE (70710-1033-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70710103308

NDC 970710-1033
NDC 1070710-1033-8
NDC Item70710103308
Packaging21 CAPSULE in 1 BOTTLE (70710-1033-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167901

NDC 970771-1679
NDC 1070771-1679-1
NDC Item70771167901
Packaging100 CAPSULE in 1 BOTTLE (70771-1679-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167908

NDC 970771-1679
NDC 1070771-1679-8
NDC Item70771167908
Packaging21 CAPSULE in 1 BOTTLE (70771-1679-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 76282069947

NDC 976282-699
NDC 1076282-699-47
NDC Item76282069947
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-699-47)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id792852
Imprint codeCipla15mg;383
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 00378194101

NDC 90378-1941
NDC 100378-1941-01
NDC Item00378194101
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194121

NDC 90378-1941
NDC 100378-1941-21
NDC Item00378194121
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124421

NDC 90480-1244
NDC 100480-1244-21
NDC Item00480124421
Packaging21 CAPSULE in 1 BOTTLE (0480-1244-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;15mg
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 31722026001

NDC 931722-260
NDC 1031722-260-01
NDC Item31722026001
Packaging100 CAPSULE in 1 BOTTLE (31722-260-01)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026021

NDC 931722-260
NDC 1031722-260-21
NDC Item31722026021
Packaging21 CAPSULE in 1 BOTTLE (31722-260-21)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051301

NDC 943598-513
NDC 1043598-513-01
NDC Item43598051301
Packaging100 CAPSULE in 1 BOTTLE (43598-513-01)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43598051321

NDC 943598-513
NDC 1043598-513-21
NDC Item43598051321
Packaging21 CAPSULE in 1 BOTTLE (43598-513-21)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 47781048601

NDC 947781-486
NDC 1047781-486-01
NDC Item47781048601
Packaging100 CAPSULE in 1 BOTTLE (47781-486-01)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 47781048677

NDC 947781-486
NDC 1047781-486-77
NDC Item47781048677
Packaging21 CAPSULE in 1 BOTTLE (47781-486-77)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 59651034501

NDC 959651-345
NDC 1059651-345-01
NDC Item59651034501
Packaging100 CAPSULE in 1 BOTTLE (59651-345-01)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034507

NDC 959651-345
NDC 1059651-345-07
NDC Item59651034507
Packaging1 BLISTER PACK in 1 CARTON (59651-345-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034521

NDC 959651-345
NDC 1059651-345-21
NDC Item59651034521
Packaging21 CAPSULE in 1 BOTTLE (59651-345-21)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453501

NDC 960505-4535
NDC 1060505-4535-1
NDC Item60505453501
Packaging100 CAPSULE in 1 BOTTLE (60505-4535-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 60505453502

NDC 960505-4535
NDC 1060505-4535-2
NDC Item60505453502
Packaging21 CAPSULE in 1 BOTTLE (60505-4535-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63304004401

NDC 963304-044
NDC 1063304-044-01
NDC Item63304004401
Packaging100 CAPSULE in 1 BOTTLE (63304-044-01)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004422

NDC 963304-044
NDC 1063304-044-22
NDC Item63304004422
Packaging21 CAPSULE in 1 BOTTLE (63304-044-22)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038381

NDC 969097-383
NDC 1069097-383-81
NDC Item69097038381
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-383-81)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id698711
Imprint codeCipla15mg;383
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 70710103301

NDC 970710-1033
NDC 1070710-1033-1
NDC Item70710103301
Packaging100 CAPSULE in 1 BOTTLE (70710-1033-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70710103308

NDC 970710-1033
NDC 1070710-1033-8
NDC Item70710103308
Packaging21 CAPSULE in 1 BOTTLE (70710-1033-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167901

NDC 970771-1679
NDC 1070771-1679-1
NDC Item70771167901
Packaging100 CAPSULE in 1 BOTTLE (70771-1679-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167908

NDC 970771-1679
NDC 1070771-1679-8
NDC Item70771167908
Packaging21 CAPSULE in 1 BOTTLE (70771-1679-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 76282069947

NDC 976282-699
NDC 1076282-699-47
NDC Item76282069947
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-699-47)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id792852
Imprint codeCipla15mg;383
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 00378194101

NDC 90378-1941
NDC 100378-1941-01
NDC Item00378194101
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194121

NDC 90378-1941
NDC 100378-1941-21
NDC Item00378194121
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124421

NDC 90480-1244
NDC 100480-1244-21
NDC Item00480124421
Packaging21 CAPSULE in 1 BOTTLE (0480-1244-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;15mg
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 31722026001

NDC 931722-260
NDC 1031722-260-01
NDC Item31722026001
Packaging100 CAPSULE in 1 BOTTLE (31722-260-01)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026021

NDC 931722-260
NDC 1031722-260-21
NDC Item31722026021
Packaging21 CAPSULE in 1 BOTTLE (31722-260-21)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051301

NDC 943598-513
NDC 1043598-513-01
NDC Item43598051301
Packaging100 CAPSULE in 1 BOTTLE (43598-513-01)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43598051321

NDC 943598-513
NDC 1043598-513-21
NDC Item43598051321
Packaging21 CAPSULE in 1 BOTTLE (43598-513-21)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 47781048601

NDC 947781-486
NDC 1047781-486-01
NDC Item47781048601
Packaging100 CAPSULE in 1 BOTTLE (47781-486-01)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 47781048677

NDC 947781-486
NDC 1047781-486-77
NDC Item47781048677
Packaging21 CAPSULE in 1 BOTTLE (47781-486-77)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 59651034501

NDC 959651-345
NDC 1059651-345-01
NDC Item59651034501
Packaging100 CAPSULE in 1 BOTTLE (59651-345-01)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034507

NDC 959651-345
NDC 1059651-345-07
NDC Item59651034507
Packaging1 BLISTER PACK in 1 CARTON (59651-345-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034521

NDC 959651-345
NDC 1059651-345-21
NDC Item59651034521
Packaging21 CAPSULE in 1 BOTTLE (59651-345-21)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453501

NDC 960505-4535
NDC 1060505-4535-1
NDC Item60505453501
Packaging100 CAPSULE in 1 BOTTLE (60505-4535-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 60505453502

NDC 960505-4535
NDC 1060505-4535-2
NDC Item60505453502
Packaging21 CAPSULE in 1 BOTTLE (60505-4535-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63304004401

NDC 963304-044
NDC 1063304-044-01
NDC Item63304004401
Packaging100 CAPSULE in 1 BOTTLE (63304-044-01)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004422

NDC 963304-044
NDC 1063304-044-22
NDC Item63304004422
Packaging21 CAPSULE in 1 BOTTLE (63304-044-22)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038381

NDC 969097-383
NDC 1069097-383-81
NDC Item69097038381
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-383-81)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id698711
Imprint codeCipla15mg;383
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 70710103301

NDC 970710-1033
NDC 1070710-1033-1
NDC Item70710103301
Packaging100 CAPSULE in 1 BOTTLE (70710-1033-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70710103308

NDC 970710-1033
NDC 1070710-1033-8
NDC Item70710103308
Packaging21 CAPSULE in 1 BOTTLE (70710-1033-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167901

NDC 970771-1679
NDC 1070771-1679-1
NDC Item70771167901
Packaging100 CAPSULE in 1 BOTTLE (70771-1679-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167908

NDC 970771-1679
NDC 1070771-1679-8
NDC Item70771167908
Packaging21 CAPSULE in 1 BOTTLE (70771-1679-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 76282069947

NDC 976282-699
NDC 1076282-699-47
NDC Item76282069947
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-699-47)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id792852
Imprint codeCipla15mg;383
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 00378194101

NDC 90378-1941
NDC 100378-1941-01
NDC Item00378194101
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194121

NDC 90378-1941
NDC 100378-1941-21
NDC Item00378194121
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124421

NDC 90480-1244
NDC 100480-1244-21
NDC Item00480124421
Packaging21 CAPSULE in 1 BOTTLE (0480-1244-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;15mg
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 31722026001

NDC 931722-260
NDC 1031722-260-01
NDC Item31722026001
Packaging100 CAPSULE in 1 BOTTLE (31722-260-01)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026021

NDC 931722-260
NDC 1031722-260-21
NDC Item31722026021
Packaging21 CAPSULE in 1 BOTTLE (31722-260-21)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051301

NDC 943598-513
NDC 1043598-513-01
NDC Item43598051301
Packaging100 CAPSULE in 1 BOTTLE (43598-513-01)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43598051321

NDC 943598-513
NDC 1043598-513-21
NDC Item43598051321
Packaging21 CAPSULE in 1 BOTTLE (43598-513-21)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 47781048601

NDC 947781-486
NDC 1047781-486-01
NDC Item47781048601
Packaging100 CAPSULE in 1 BOTTLE (47781-486-01)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 47781048677

NDC 947781-486
NDC 1047781-486-77
NDC Item47781048677
Packaging21 CAPSULE in 1 BOTTLE (47781-486-77)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 59651034501

NDC 959651-345
NDC 1059651-345-01
NDC Item59651034501
Packaging100 CAPSULE in 1 BOTTLE (59651-345-01)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034507

NDC 959651-345
NDC 1059651-345-07
NDC Item59651034507
Packaging1 BLISTER PACK in 1 CARTON (59651-345-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034521

NDC 959651-345
NDC 1059651-345-21
NDC Item59651034521
Packaging21 CAPSULE in 1 BOTTLE (59651-345-21)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453501

NDC 960505-4535
NDC 1060505-4535-1
NDC Item60505453501
Packaging100 CAPSULE in 1 BOTTLE (60505-4535-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 60505453502

NDC 960505-4535
NDC 1060505-4535-2
NDC Item60505453502
Packaging21 CAPSULE in 1 BOTTLE (60505-4535-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63304004401

NDC 963304-044
NDC 1063304-044-01
NDC Item63304004401
Packaging100 CAPSULE in 1 BOTTLE (63304-044-01)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004422

NDC 963304-044
NDC 1063304-044-22
NDC Item63304004422
Packaging21 CAPSULE in 1 BOTTLE (63304-044-22)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038381

NDC 969097-383
NDC 1069097-383-81
NDC Item69097038381
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-383-81)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id698711
Imprint codeCipla15mg;383
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 70710103301

NDC 970710-1033
NDC 1070710-1033-1
NDC Item70710103301
Packaging100 CAPSULE in 1 BOTTLE (70710-1033-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70710103308

NDC 970710-1033
NDC 1070710-1033-8
NDC Item70710103308
Packaging21 CAPSULE in 1 BOTTLE (70710-1033-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167901

NDC 970771-1679
NDC 1070771-1679-1
NDC Item70771167901
Packaging100 CAPSULE in 1 BOTTLE (70771-1679-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167908

NDC 970771-1679
NDC 1070771-1679-8
NDC Item70771167908
Packaging21 CAPSULE in 1 BOTTLE (70771-1679-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 76282069947

NDC 976282-699
NDC 1076282-699-47
NDC Item76282069947
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-699-47)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id792852
Imprint codeCipla15mg;383
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 00378194101

NDC 90378-1941
NDC 100378-1941-01
NDC Item00378194101
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194121

NDC 90378-1941
NDC 100378-1941-21
NDC Item00378194121
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124421

NDC 90480-1244
NDC 100480-1244-21
NDC Item00480124421
Packaging21 CAPSULE in 1 BOTTLE (0480-1244-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;15mg
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 31722026001

NDC 931722-260
NDC 1031722-260-01
NDC Item31722026001
Packaging100 CAPSULE in 1 BOTTLE (31722-260-01)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026021

NDC 931722-260
NDC 1031722-260-21
NDC Item31722026021
Packaging21 CAPSULE in 1 BOTTLE (31722-260-21)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051301

NDC 943598-513
NDC 1043598-513-01
NDC Item43598051301
Packaging100 CAPSULE in 1 BOTTLE (43598-513-01)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43598051321

NDC 943598-513
NDC 1043598-513-21
NDC Item43598051321
Packaging21 CAPSULE in 1 BOTTLE (43598-513-21)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 47781048601

NDC 947781-486
NDC 1047781-486-01
NDC Item47781048601
Packaging100 CAPSULE in 1 BOTTLE (47781-486-01)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 47781048677

NDC 947781-486
NDC 1047781-486-77
NDC Item47781048677
Packaging21 CAPSULE in 1 BOTTLE (47781-486-77)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 59651034501

NDC 959651-345
NDC 1059651-345-01
NDC Item59651034501
Packaging100 CAPSULE in 1 BOTTLE (59651-345-01)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034507

NDC 959651-345
NDC 1059651-345-07
NDC Item59651034507
Packaging1 BLISTER PACK in 1 CARTON (59651-345-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034521

NDC 959651-345
NDC 1059651-345-21
NDC Item59651034521
Packaging21 CAPSULE in 1 BOTTLE (59651-345-21)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453501

NDC 960505-4535
NDC 1060505-4535-1
NDC Item60505453501
Packaging100 CAPSULE in 1 BOTTLE (60505-4535-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 60505453502

NDC 960505-4535
NDC 1060505-4535-2
NDC Item60505453502
Packaging21 CAPSULE in 1 BOTTLE (60505-4535-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63304004401

NDC 963304-044
NDC 1063304-044-01
NDC Item63304004401
Packaging100 CAPSULE in 1 BOTTLE (63304-044-01)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004422

NDC 963304-044
NDC 1063304-044-22
NDC Item63304004422
Packaging21 CAPSULE in 1 BOTTLE (63304-044-22)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038381

NDC 969097-383
NDC 1069097-383-81
NDC Item69097038381
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-383-81)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id698711
Imprint codeCipla15mg;383
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 70710103301

NDC 970710-1033
NDC 1070710-1033-1
NDC Item70710103301
Packaging100 CAPSULE in 1 BOTTLE (70710-1033-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70710103308

NDC 970710-1033
NDC 1070710-1033-8
NDC Item70710103308
Packaging21 CAPSULE in 1 BOTTLE (70710-1033-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167901

NDC 970771-1679
NDC 1070771-1679-1
NDC Item70771167901
Packaging100 CAPSULE in 1 BOTTLE (70771-1679-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167908

NDC 970771-1679
NDC 1070771-1679-8
NDC Item70771167908
Packaging21 CAPSULE in 1 BOTTLE (70771-1679-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 76282069947

NDC 976282-699
NDC 1076282-699-47
NDC Item76282069947
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-699-47)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id792852
Imprint codeCipla15mg;383
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 00378194101

NDC 90378-1941
NDC 100378-1941-01
NDC Item00378194101
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194121

NDC 90378-1941
NDC 100378-1941-21
NDC Item00378194121
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124421

NDC 90480-1244
NDC 100480-1244-21
NDC Item00480124421
Packaging21 CAPSULE in 1 BOTTLE (0480-1244-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;15mg
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 31722026001

NDC 931722-260
NDC 1031722-260-01
NDC Item31722026001
Packaging100 CAPSULE in 1 BOTTLE (31722-260-01)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026021

NDC 931722-260
NDC 1031722-260-21
NDC Item31722026021
Packaging21 CAPSULE in 1 BOTTLE (31722-260-21)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051301

NDC 943598-513
NDC 1043598-513-01
NDC Item43598051301
Packaging100 CAPSULE in 1 BOTTLE (43598-513-01)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43598051321

NDC 943598-513
NDC 1043598-513-21
NDC Item43598051321
Packaging21 CAPSULE in 1 BOTTLE (43598-513-21)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 47781048601

NDC 947781-486
NDC 1047781-486-01
NDC Item47781048601
Packaging100 CAPSULE in 1 BOTTLE (47781-486-01)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 47781048677

NDC 947781-486
NDC 1047781-486-77
NDC Item47781048677
Packaging21 CAPSULE in 1 BOTTLE (47781-486-77)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 59651034501

NDC 959651-345
NDC 1059651-345-01
NDC Item59651034501
Packaging100 CAPSULE in 1 BOTTLE (59651-345-01)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034507

NDC 959651-345
NDC 1059651-345-07
NDC Item59651034507
Packaging1 BLISTER PACK in 1 CARTON (59651-345-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034521

NDC 959651-345
NDC 1059651-345-21
NDC Item59651034521
Packaging21 CAPSULE in 1 BOTTLE (59651-345-21)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453501

NDC 960505-4535
NDC 1060505-4535-1
NDC Item60505453501
Packaging100 CAPSULE in 1 BOTTLE (60505-4535-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 60505453502

NDC 960505-4535
NDC 1060505-4535-2
NDC Item60505453502
Packaging21 CAPSULE in 1 BOTTLE (60505-4535-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63304004401

NDC 963304-044
NDC 1063304-044-01
NDC Item63304004401
Packaging100 CAPSULE in 1 BOTTLE (63304-044-01)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004422

NDC 963304-044
NDC 1063304-044-22
NDC Item63304004422
Packaging21 CAPSULE in 1 BOTTLE (63304-044-22)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038381

NDC 969097-383
NDC 1069097-383-81
NDC Item69097038381
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-383-81)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id698711
Imprint codeCipla15mg;383
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 70710103301

NDC 970710-1033
NDC 1070710-1033-1
NDC Item70710103301
Packaging100 CAPSULE in 1 BOTTLE (70710-1033-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70710103308

NDC 970710-1033
NDC 1070710-1033-8
NDC Item70710103308
Packaging21 CAPSULE in 1 BOTTLE (70710-1033-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167901

NDC 970771-1679
NDC 1070771-1679-1
NDC Item70771167901
Packaging100 CAPSULE in 1 BOTTLE (70771-1679-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167908

NDC 970771-1679
NDC 1070771-1679-8
NDC Item70771167908
Packaging21 CAPSULE in 1 BOTTLE (70771-1679-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 76282069947

NDC 976282-699
NDC 1076282-699-47
NDC Item76282069947
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-699-47)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id792852
Imprint codeCipla15mg;383
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 00378194101

NDC 90378-1941
NDC 100378-1941-01
NDC Item00378194101
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194121

NDC 90378-1941
NDC 100378-1941-21
NDC Item00378194121
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124421

NDC 90480-1244
NDC 100480-1244-21
NDC Item00480124421
Packaging21 CAPSULE in 1 BOTTLE (0480-1244-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;15mg
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 31722026001

NDC 931722-260
NDC 1031722-260-01
NDC Item31722026001
Packaging100 CAPSULE in 1 BOTTLE (31722-260-01)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026021

NDC 931722-260
NDC 1031722-260-21
NDC Item31722026021
Packaging21 CAPSULE in 1 BOTTLE (31722-260-21)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051301

NDC 943598-513
NDC 1043598-513-01
NDC Item43598051301
Packaging100 CAPSULE in 1 BOTTLE (43598-513-01)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43598051321

NDC 943598-513
NDC 1043598-513-21
NDC Item43598051321
Packaging21 CAPSULE in 1 BOTTLE (43598-513-21)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 47781048601

NDC 947781-486
NDC 1047781-486-01
NDC Item47781048601
Packaging100 CAPSULE in 1 BOTTLE (47781-486-01)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 47781048677

NDC 947781-486
NDC 1047781-486-77
NDC Item47781048677
Packaging21 CAPSULE in 1 BOTTLE (47781-486-77)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 59651034501

NDC 959651-345
NDC 1059651-345-01
NDC Item59651034501
Packaging100 CAPSULE in 1 BOTTLE (59651-345-01)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034507

NDC 959651-345
NDC 1059651-345-07
NDC Item59651034507
Packaging1 BLISTER PACK in 1 CARTON (59651-345-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034521

NDC 959651-345
NDC 1059651-345-21
NDC Item59651034521
Packaging21 CAPSULE in 1 BOTTLE (59651-345-21)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453501

NDC 960505-4535
NDC 1060505-4535-1
NDC Item60505453501
Packaging100 CAPSULE in 1 BOTTLE (60505-4535-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 60505453502

NDC 960505-4535
NDC 1060505-4535-2
NDC Item60505453502
Packaging21 CAPSULE in 1 BOTTLE (60505-4535-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63304004401

NDC 963304-044
NDC 1063304-044-01
NDC Item63304004401
Packaging100 CAPSULE in 1 BOTTLE (63304-044-01)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004422

NDC 963304-044
NDC 1063304-044-22
NDC Item63304004422
Packaging21 CAPSULE in 1 BOTTLE (63304-044-22)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038381

NDC 969097-383
NDC 1069097-383-81
NDC Item69097038381
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-383-81)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id698711
Imprint codeCipla15mg;383
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 70710103301

NDC 970710-1033
NDC 1070710-1033-1
NDC Item70710103301
Packaging100 CAPSULE in 1 BOTTLE (70710-1033-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70710103308

NDC 970710-1033
NDC 1070710-1033-8
NDC Item70710103308
Packaging21 CAPSULE in 1 BOTTLE (70710-1033-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167901

NDC 970771-1679
NDC 1070771-1679-1
NDC Item70771167901
Packaging100 CAPSULE in 1 BOTTLE (70771-1679-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167908

NDC 970771-1679
NDC 1070771-1679-8
NDC Item70771167908
Packaging21 CAPSULE in 1 BOTTLE (70771-1679-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 76282069947

NDC 976282-699
NDC 1076282-699-47
NDC Item76282069947
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-699-47)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id792852
Imprint codeCipla15mg;383
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 00378194101

NDC 90378-1941
NDC 100378-1941-01
NDC Item00378194101
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194121

NDC 90378-1941
NDC 100378-1941-21
NDC Item00378194121
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124421

NDC 90480-1244
NDC 100480-1244-21
NDC Item00480124421
Packaging21 CAPSULE in 1 BOTTLE (0480-1244-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;15mg
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 31722026001

NDC 931722-260
NDC 1031722-260-01
NDC Item31722026001
Packaging100 CAPSULE in 1 BOTTLE (31722-260-01)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026021

NDC 931722-260
NDC 1031722-260-21
NDC Item31722026021
Packaging21 CAPSULE in 1 BOTTLE (31722-260-21)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051301

NDC 943598-513
NDC 1043598-513-01
NDC Item43598051301
Packaging100 CAPSULE in 1 BOTTLE (43598-513-01)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43598051321

NDC 943598-513
NDC 1043598-513-21
NDC Item43598051321
Packaging21 CAPSULE in 1 BOTTLE (43598-513-21)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 47781048601

NDC 947781-486
NDC 1047781-486-01
NDC Item47781048601
Packaging100 CAPSULE in 1 BOTTLE (47781-486-01)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 47781048677

NDC 947781-486
NDC 1047781-486-77
NDC Item47781048677
Packaging21 CAPSULE in 1 BOTTLE (47781-486-77)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 59651034501

NDC 959651-345
NDC 1059651-345-01
NDC Item59651034501
Packaging100 CAPSULE in 1 BOTTLE (59651-345-01)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034507

NDC 959651-345
NDC 1059651-345-07
NDC Item59651034507
Packaging1 BLISTER PACK in 1 CARTON (59651-345-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034521

NDC 959651-345
NDC 1059651-345-21
NDC Item59651034521
Packaging21 CAPSULE in 1 BOTTLE (59651-345-21)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453501

NDC 960505-4535
NDC 1060505-4535-1
NDC Item60505453501
Packaging100 CAPSULE in 1 BOTTLE (60505-4535-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 60505453502

NDC 960505-4535
NDC 1060505-4535-2
NDC Item60505453502
Packaging21 CAPSULE in 1 BOTTLE (60505-4535-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63304004401

NDC 963304-044
NDC 1063304-044-01
NDC Item63304004401
Packaging100 CAPSULE in 1 BOTTLE (63304-044-01)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004422

NDC 963304-044
NDC 1063304-044-22
NDC Item63304004422
Packaging21 CAPSULE in 1 BOTTLE (63304-044-22)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038381

NDC 969097-383
NDC 1069097-383-81
NDC Item69097038381
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-383-81)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id698711
Imprint codeCipla15mg;383
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 70710103301

NDC 970710-1033
NDC 1070710-1033-1
NDC Item70710103301
Packaging100 CAPSULE in 1 BOTTLE (70710-1033-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70710103308

NDC 970710-1033
NDC 1070710-1033-8
NDC Item70710103308
Packaging21 CAPSULE in 1 BOTTLE (70710-1033-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167901

NDC 970771-1679
NDC 1070771-1679-1
NDC Item70771167901
Packaging100 CAPSULE in 1 BOTTLE (70771-1679-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167908

NDC 970771-1679
NDC 1070771-1679-8
NDC Item70771167908
Packaging21 CAPSULE in 1 BOTTLE (70771-1679-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 76282069947

NDC 976282-699
NDC 1076282-699-47
NDC Item76282069947
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-699-47)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id792852
Imprint codeCipla15mg;383
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 00378194101

NDC 90378-1941
NDC 100378-1941-01
NDC Item00378194101
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194121

NDC 90378-1941
NDC 100378-1941-21
NDC Item00378194121
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124421

NDC 90480-1244
NDC 100480-1244-21
NDC Item00480124421
Packaging21 CAPSULE in 1 BOTTLE (0480-1244-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;15mg
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 31722026001

NDC 931722-260
NDC 1031722-260-01
NDC Item31722026001
Packaging100 CAPSULE in 1 BOTTLE (31722-260-01)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026021

NDC 931722-260
NDC 1031722-260-21
NDC Item31722026021
Packaging21 CAPSULE in 1 BOTTLE (31722-260-21)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051301

NDC 943598-513
NDC 1043598-513-01
NDC Item43598051301
Packaging100 CAPSULE in 1 BOTTLE (43598-513-01)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43598051321

NDC 943598-513
NDC 1043598-513-21
NDC Item43598051321
Packaging21 CAPSULE in 1 BOTTLE (43598-513-21)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 47781048601

NDC 947781-486
NDC 1047781-486-01
NDC Item47781048601
Packaging100 CAPSULE in 1 BOTTLE (47781-486-01)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 47781048677

NDC 947781-486
NDC 1047781-486-77
NDC Item47781048677
Packaging21 CAPSULE in 1 BOTTLE (47781-486-77)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 59651034501

NDC 959651-345
NDC 1059651-345-01
NDC Item59651034501
Packaging100 CAPSULE in 1 BOTTLE (59651-345-01)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034507

NDC 959651-345
NDC 1059651-345-07
NDC Item59651034507
Packaging1 BLISTER PACK in 1 CARTON (59651-345-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034521

NDC 959651-345
NDC 1059651-345-21
NDC Item59651034521
Packaging21 CAPSULE in 1 BOTTLE (59651-345-21)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453501

NDC 960505-4535
NDC 1060505-4535-1
NDC Item60505453501
Packaging100 CAPSULE in 1 BOTTLE (60505-4535-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 60505453502

NDC 960505-4535
NDC 1060505-4535-2
NDC Item60505453502
Packaging21 CAPSULE in 1 BOTTLE (60505-4535-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63304004401

NDC 963304-044
NDC 1063304-044-01
NDC Item63304004401
Packaging100 CAPSULE in 1 BOTTLE (63304-044-01)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004422

NDC 963304-044
NDC 1063304-044-22
NDC Item63304004422
Packaging21 CAPSULE in 1 BOTTLE (63304-044-22)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038381

NDC 969097-383
NDC 1069097-383-81
NDC Item69097038381
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-383-81)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id698711
Imprint codeCipla15mg;383
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 70710103301

NDC 970710-1033
NDC 1070710-1033-1
NDC Item70710103301
Packaging100 CAPSULE in 1 BOTTLE (70710-1033-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70710103308

NDC 970710-1033
NDC 1070710-1033-8
NDC Item70710103308
Packaging21 CAPSULE in 1 BOTTLE (70710-1033-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167901

NDC 970771-1679
NDC 1070771-1679-1
NDC Item70771167901
Packaging100 CAPSULE in 1 BOTTLE (70771-1679-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167908

NDC 970771-1679
NDC 1070771-1679-8
NDC Item70771167908
Packaging21 CAPSULE in 1 BOTTLE (70771-1679-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 76282069947

NDC 976282-699
NDC 1076282-699-47
NDC Item76282069947
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-699-47)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id792852
Imprint codeCipla15mg;383
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 00378194101

NDC 90378-1941
NDC 100378-1941-01
NDC Item00378194101
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-01)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00378194121

NDC 90378-1941
NDC 100378-1941-21
NDC Item00378194121
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (0378-1941-21)
ANDAANDA213912
COLORTEXTWHITE(white opaque)
ColorC48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;15
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 00480124421

NDC 90480-1244
NDC 100480-1244-21
NDC Item00480124421
Packaging21 CAPSULE in 1 BOTTLE (0480-1244-21)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id644159
Imprint codeNAT;15mg
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 31722026001

NDC 931722-260
NDC 1031722-260-01
NDC Item31722026001
Packaging100 CAPSULE in 1 BOTTLE (31722-260-01)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 31722026021

NDC 931722-260
NDC 1031722-260-21
NDC Item31722026021
Packaging21 CAPSULE in 1 BOTTLE (31722-260-21)
ANDAANDA212414
COLORTEXTwhite,red
ColorC48325;C48326 __
FDA SPL set id802288
Imprint codeH;L5
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size22 mm
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NDC Item 43598051301

NDC 943598-513
NDC 1043598-513-01
NDC Item43598051301
Packaging100 CAPSULE in 1 BOTTLE (43598-513-01)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 43598051321

NDC 943598-513
NDC 1043598-513-21
NDC Item43598051321
Packaging21 CAPSULE in 1 BOTTLE (43598-513-21)
ANDAANDA209348
COLORTEXTBLUE(blue opaque colored cap and body)
ColorC48333 __
FDA SPL set id727151
Imprint codeRDY;15;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 47781048601

NDC 947781-486
NDC 1047781-486-01
NDC Item47781048601
Packaging100 CAPSULE in 1 BOTTLE (47781-486-01)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 47781048677

NDC 947781-486
NDC 1047781-486-77
NDC Item47781048677
Packaging21 CAPSULE in 1 BOTTLE (47781-486-77)
ANDAANDA210480
COLORTEXTBROWN(caramel),GRAY
ColorC48332;C48324 __
FDA SPL set id789803
Imprint codeLP;640
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 59651034501

NDC 959651-345
NDC 1059651-345-01
NDC Item59651034501
Packaging100 CAPSULE in 1 BOTTLE (59651-345-01)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034507

NDC 959651-345
NDC 1059651-345-07
NDC Item59651034507
Packaging1 BLISTER PACK in 1 CARTON (59651-345-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 59651034521

NDC 959651-345
NDC 1059651-345-21
NDC Item59651034521
Packaging21 CAPSULE in 1 BOTTLE (59651-345-21)
ANDAANDA213885
COLORTEXTORANGE(Dark Orange Opaque Cap, Dark Orange Opaque Body)
ColorC48331 __
FDA SPL set id717399
Imprint codeL;15
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 60505453501

NDC 960505-4535
NDC 1060505-4535-1
NDC Item60505453501
Packaging100 CAPSULE in 1 BOTTLE (60505-4535-1)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 60505453502

NDC 960505-4535
NDC 1060505-4535-2
NDC Item60505453502
Packaging21 CAPSULE in 1 BOTTLE (60505-4535-2)
ANDAANDA211022
COLORTEXTWHITE(White opaque),BLUE(Powder blue opaque)
ColorC48325;C48333 __
FDA SPL set id794910
Imprint codeAPO;L15
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size19 mm
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NDC Item 63304004401

NDC 963304-044
NDC 1063304-044-01
NDC Item63304004401
Packaging100 CAPSULE in 1 BOTTLE (63304-044-01)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 63304004422

NDC 963304-044
NDC 1063304-044-22
NDC Item63304004422
Packaging21 CAPSULE in 1 BOTTLE (63304-044-22)
ANDAANDA211846
COLORTEXTwhite,WHITE
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;81
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-04
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
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NDC Item 69097038381

NDC 969097-383
NDC 1069097-383-81
NDC Item69097038381
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (69097-383-81)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id698711
Imprint codeCipla15mg;383
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 69097-383

NDC Item 70710103301

NDC 970710-1033
NDC 1070710-1033-1
NDC Item70710103301
Packaging100 CAPSULE in 1 BOTTLE (70710-1033-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70710103308

NDC 970710-1033
NDC 1070710-1033-8
NDC Item70710103308
Packaging21 CAPSULE in 1 BOTTLE (70710-1033-8)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap),BLUE(Light blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1033
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
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NDC Item 70771167901

NDC 970771-1679
NDC 1070771-1679-1
NDC Item70771167901
Packaging100 CAPSULE in 1 BOTTLE (70771-1679-1)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 70771-1679

NDC Item 70771167908

NDC 970771-1679
NDC 1070771-1679-8
NDC Item70771167908
Packaging21 CAPSULE in 1 BOTTLE (70771-1679-8)
ANDAANDA210154
COLORTEXTWHITE(White opaque cap),BLUE(Light Blue opaque body)
ColorC48325;C48333 __
FDA SPL set id800438
Imprint code1033
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-12
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size18 mm
Related queriesProperties for NDC 9 70771-1679

NDC Item 76282069947

NDC 976282-699
NDC 1076282-699-47
NDC Item76282069947
Packaging21 CAPSULE in 1 BOTTLE, PLASTIC (76282-699-47)
ANDAANDA210435
COLORTEXTBLUE(pale blue and white)
ColorC48333 __
FDA SPL set id792852
Imprint codeCipla15mg;383
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size21 mm
Related queriesProperties for NDC 9 76282-699