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HomeSearchRxCUI 1242231: Brands

NDC properties for "lenalidomide 2.5 MG Oral Capsule" (RxCUI 1242231)

About this data

The tables show NDC propoerties for lenalidomide 2.5 MG Oral Capsule with the RxCUI 1242231

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 2.5 MG Oral Capsule (RxCUI 1242231)

ANDAANDA201452
ANDAANDA209348
ANDAANDA210154
ANDAANDA210480
ANDAANDA211022
ANDAANDA211846
ANDAANDA212414
ANDAANDA213885
ANDAANDA213912
ANDAANDA214618
MMSL_CODEBD27635
MMSL_CODECD27635
RxCUI1242231
SNOMEDCT840661007
SPL_SET_ID51bfdd53-8fd9-4f86-bebe-75de29e6379d
SPL_SET_ID76f6c1e7-985b-43d9-892c-849df50ae80e
SPL_SET_ID84d9dec7-9250-4dbd-9a0d-23e75f111892
SPL_SET_ID85f5db5d-8f76-46f6-b975-6acda8c4b2c8
SPL_SET_ID96df285d-dd13-4083-b2c6-e5c799e7587b
SPL_SET_ID9943e098-20b0-dbb3-af12-7816eedd3f70
SPL_SET_ID9d401422-072b-4b69-aeef-da1f9534c3ec
SPL_SET_IDadee5af1-c9ab-c0c7-e400-dea7d2a0d4be
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
VUID4031575
Prescribable Synonymlenalidomide 2.5 MG Oral Capsule
RXNAV_STRlenalidomide 2.5 MG Oral Capsule
RxNorm Namelenalidomide 2.5 MG Oral Capsule
Related queriesInteractions (for RxCUI 1242231)



NDC Properties

NDC Item 00378193501

NDC 90378-1935
NDC 100378-1935-01
NDC Item00378193501
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-01)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-1935

NDC Item 00378193528

NDC 90378-1935
NDC 100378-1935-28
NDC Item00378193528
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-28)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-1935

NDC Item 00480124128

NDC 90480-1241
NDC 100480-1241-28
NDC Item00480124128
Packaging28 CAPSULE in 1 BOTTLE (0480-1241-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id782674
Imprint codeNAT;2;5mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-08
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0480-1241

NDC Item 31722025701

NDC 931722-257
NDC 1031722-257-01
NDC Item31722025701
Packaging100 CAPSULE in 1 BOTTLE (31722-257-01)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
Related queriesProperties for NDC 9 31722-257

NDC Item 31722025728

NDC 931722-257
NDC 1031722-257-28
NDC Item31722025728
Packaging28 CAPSULE in 1 BOTTLE (31722-257-28)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
Related queriesProperties for NDC 9 31722-257

NDC Item 43598051601

NDC 943598-516
NDC 1043598-516-01
NDC Item43598051601
Packaging100 CAPSULE in 1 BOTTLE (43598-516-01)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43598-516

NDC Item 43598051663

NDC 943598-516
NDC 1043598-516-63
NDC Item43598051663
Packaging28 CAPSULE in 1 BOTTLE (43598-516-63)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43598-516

NDC Item 47781048301

NDC 947781-483
NDC 1047781-483-01
NDC Item47781048301
Packaging100 CAPSULE in 1 BOTTLE (47781-483-01)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 47781-483

NDC Item 47781048328

NDC 947781-483
NDC 1047781-483-28
NDC Item47781048328
Packaging28 CAPSULE in 1 BOTTLE (47781-483-28)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 47781-483

NDC Item 59651034201

NDC 959651-342
NDC 1059651-342-01
NDC Item59651034201
Packaging100 CAPSULE in 1 BOTTLE (59651-342-01)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 59651-342

NDC Item 59651034207

NDC 959651-342
NDC 1059651-342-07
NDC Item59651034207
Packaging1 BLISTER PACK in 1 CARTON (59651-342-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 59651-342

NDC Item 59651034228

NDC 959651-342
NDC 1059651-342-28
NDC Item59651034228
Packaging28 CAPSULE in 1 BOTTLE (59651-342-28)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 59651-342

NDC Item 60505453202

NDC 960505-4532
NDC 1060505-4532-2
NDC Item60505453202
Packaging28 CAPSULE in 1 BOTTLE (60505-4532-2)
ANDAANDA211022
COLORTEXTWHITE(Opaque),BLUE(Blue green opaque)
ColorC48325;C48333 __
FDA SPL set id707296
Imprint codeAPO;L;2;5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 60505-4532

NDC Item 63304004101

NDC 963304-041
NDC 1063304-041-01
NDC Item63304004101
Packaging100 CAPSULE in 1 BOTTLE (63304-041-01)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63304-041

NDC Item 63304004127

NDC 963304-041
NDC 1063304-041-27
NDC Item63304004127
Packaging28 CAPSULE in 1 BOTTLE (63304-041-27)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63304-041

NDC Item 69097060473

NDC 969097-604
NDC 1069097-604-73
NDC Item69097060473
Packaging28 CAPSULE in 1 BOTTLE (69097-604-73)
ANDAANDA214618
COLORTEXTBLUE(blue green cap),WHITE(white body)
ColorC48333;C48325 __
FDA SPL set id699517
Imprint codeCipla;2;5mg;604
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 69097-604

NDC Item 70710103001

NDC 970710-1030
NDC 1070710-1030-1
NDC Item70710103001
Packaging100 CAPSULE in 1 BOTTLE (70710-1030-1)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
Related queriesProperties for NDC 9 70710-1030

NDC Item 70710103007

NDC 970710-1030
NDC 1070710-1030-7
NDC Item70710103007
Packaging28 CAPSULE in 1 BOTTLE (70710-1030-7)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
Related queriesProperties for NDC 9 70710-1030

NDC Item 70771167601

NDC 970771-1676
NDC 1070771-1676-1
NDC Item70771167601
Packaging100 CAPSULE in 1 BOTTLE (70771-1676-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
Related queriesProperties for NDC 9 70771-1676

NDC Item 70771167607

NDC 970771-1676
NDC 1070771-1676-7
NDC Item70771167607
Packaging28 CAPSULE in 1 BOTTLE (70771-1676-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
Related queriesProperties for NDC 9 70771-1676

NDC Item 76282069648

NDC 976282-696
NDC 1076282-696-48
NDC Item76282069648
Packaging28 CAPSULE in 1 BOTTLE (76282-696-48)
ANDAANDA214618
COLORTEXTBLUE(capsule blue green cap and White body)
ColorC48333 __
FDA SPL set id792335
Imprint codeCipla;2;5mg;cap;604;body
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-06-10
Marketing statusactive
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 76282-696

NDC Item 00378193501

NDC 90378-1935
NDC 100378-1935-01
NDC Item00378193501
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-01)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-1935

NDC Item 00378193528

NDC 90378-1935
NDC 100378-1935-28
NDC Item00378193528
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-28)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0378-1935

NDC Item 00480124128

NDC 90480-1241
NDC 100480-1241-28
NDC Item00480124128
Packaging28 CAPSULE in 1 BOTTLE (0480-1241-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id782674
Imprint codeNAT;2;5mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-08
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 0480-1241

NDC Item 31722025701

NDC 931722-257
NDC 1031722-257-01
NDC Item31722025701
Packaging100 CAPSULE in 1 BOTTLE (31722-257-01)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
Related queriesProperties for NDC 9 31722-257

NDC Item 31722025728

NDC 931722-257
NDC 1031722-257-28
NDC Item31722025728
Packaging28 CAPSULE in 1 BOTTLE (31722-257-28)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
Related queriesProperties for NDC 9 31722-257

NDC Item 43598051601

NDC 943598-516
NDC 1043598-516-01
NDC Item43598051601
Packaging100 CAPSULE in 1 BOTTLE (43598-516-01)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43598-516

NDC Item 43598051663

NDC 943598-516
NDC 1043598-516-63
NDC Item43598051663
Packaging28 CAPSULE in 1 BOTTLE (43598-516-63)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 43598-516

NDC Item 47781048301

NDC 947781-483
NDC 1047781-483-01
NDC Item47781048301
Packaging100 CAPSULE in 1 BOTTLE (47781-483-01)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 47781-483

NDC Item 47781048328

NDC 947781-483
NDC 1047781-483-28
NDC Item47781048328
Packaging28 CAPSULE in 1 BOTTLE (47781-483-28)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 47781-483

NDC Item 59651034201

NDC 959651-342
NDC 1059651-342-01
NDC Item59651034201
Packaging100 CAPSULE in 1 BOTTLE (59651-342-01)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 59651-342

NDC Item 59651034207

NDC 959651-342
NDC 1059651-342-07
NDC Item59651034207
Packaging1 BLISTER PACK in 1 CARTON (59651-342-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 59651-342

NDC Item 59651034228

NDC 959651-342
NDC 1059651-342-28
NDC Item59651034228
Packaging28 CAPSULE in 1 BOTTLE (59651-342-28)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 59651-342

NDC Item 60505453202

NDC 960505-4532
NDC 1060505-4532-2
NDC Item60505453202
Packaging28 CAPSULE in 1 BOTTLE (60505-4532-2)
ANDAANDA211022
COLORTEXTWHITE(Opaque),BLUE(Blue green opaque)
ColorC48325;C48333 __
FDA SPL set id707296
Imprint codeAPO;L;2;5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 60505-4532

NDC Item 63304004101

NDC 963304-041
NDC 1063304-041-01
NDC Item63304004101
Packaging100 CAPSULE in 1 BOTTLE (63304-041-01)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63304-041

NDC Item 63304004127

NDC 963304-041
NDC 1063304-041-27
NDC Item63304004127
Packaging28 CAPSULE in 1 BOTTLE (63304-041-27)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63304-041

NDC Item 69097060473

NDC 969097-604
NDC 1069097-604-73
NDC Item69097060473
Packaging28 CAPSULE in 1 BOTTLE (69097-604-73)
ANDAANDA214618
COLORTEXTBLUE(blue green cap),WHITE(white body)
ColorC48333;C48325 __
FDA SPL set id699517
Imprint codeCipla;2;5mg;604
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 69097-604

NDC Item 70710103001

NDC 970710-1030
NDC 1070710-1030-1
NDC Item70710103001
Packaging100 CAPSULE in 1 BOTTLE (70710-1030-1)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103007

NDC 970710-1030
NDC 1070710-1030-7
NDC Item70710103007
Packaging28 CAPSULE in 1 BOTTLE (70710-1030-7)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167601

NDC 970771-1676
NDC 1070771-1676-1
NDC Item70771167601
Packaging100 CAPSULE in 1 BOTTLE (70771-1676-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167607

NDC 970771-1676
NDC 1070771-1676-7
NDC Item70771167607
Packaging28 CAPSULE in 1 BOTTLE (70771-1676-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069648

NDC 976282-696
NDC 1076282-696-48
NDC Item76282069648
Packaging28 CAPSULE in 1 BOTTLE (76282-696-48)
ANDAANDA214618
COLORTEXTBLUE(capsule blue green cap and White body)
ColorC48333 __
FDA SPL set id792335
Imprint codeCipla;2;5mg;cap;604;body
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-06-10
Marketing statusactive
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193501

NDC 90378-1935
NDC 100378-1935-01
NDC Item00378193501
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-01)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193528

NDC 90378-1935
NDC 100378-1935-28
NDC Item00378193528
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-28)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00480124128

NDC 90480-1241
NDC 100480-1241-28
NDC Item00480124128
Packaging28 CAPSULE in 1 BOTTLE (0480-1241-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id782674
Imprint codeNAT;2;5mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-08
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 31722025701

NDC 931722-257
NDC 1031722-257-01
NDC Item31722025701
Packaging100 CAPSULE in 1 BOTTLE (31722-257-01)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 31722025728

NDC 931722-257
NDC 1031722-257-28
NDC Item31722025728
Packaging28 CAPSULE in 1 BOTTLE (31722-257-28)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 43598051601

NDC 943598-516
NDC 1043598-516-01
NDC Item43598051601
Packaging100 CAPSULE in 1 BOTTLE (43598-516-01)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051663

NDC 943598-516
NDC 1043598-516-63
NDC Item43598051663
Packaging28 CAPSULE in 1 BOTTLE (43598-516-63)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048301

NDC 947781-483
NDC 1047781-483-01
NDC Item47781048301
Packaging100 CAPSULE in 1 BOTTLE (47781-483-01)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048328

NDC 947781-483
NDC 1047781-483-28
NDC Item47781048328
Packaging28 CAPSULE in 1 BOTTLE (47781-483-28)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034201

NDC 959651-342
NDC 1059651-342-01
NDC Item59651034201
Packaging100 CAPSULE in 1 BOTTLE (59651-342-01)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034207

NDC 959651-342
NDC 1059651-342-07
NDC Item59651034207
Packaging1 BLISTER PACK in 1 CARTON (59651-342-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034228

NDC 959651-342
NDC 1059651-342-28
NDC Item59651034228
Packaging28 CAPSULE in 1 BOTTLE (59651-342-28)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453202

NDC 960505-4532
NDC 1060505-4532-2
NDC Item60505453202
Packaging28 CAPSULE in 1 BOTTLE (60505-4532-2)
ANDAANDA211022
COLORTEXTWHITE(Opaque),BLUE(Blue green opaque)
ColorC48325;C48333 __
FDA SPL set id707296
Imprint codeAPO;L;2;5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004101

NDC 963304-041
NDC 1063304-041-01
NDC Item63304004101
Packaging100 CAPSULE in 1 BOTTLE (63304-041-01)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004127

NDC 963304-041
NDC 1063304-041-27
NDC Item63304004127
Packaging28 CAPSULE in 1 BOTTLE (63304-041-27)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 69097060473

NDC 969097-604
NDC 1069097-604-73
NDC Item69097060473
Packaging28 CAPSULE in 1 BOTTLE (69097-604-73)
ANDAANDA214618
COLORTEXTBLUE(blue green cap),WHITE(white body)
ColorC48333;C48325 __
FDA SPL set id699517
Imprint codeCipla;2;5mg;604
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 70710103001

NDC 970710-1030
NDC 1070710-1030-1
NDC Item70710103001
Packaging100 CAPSULE in 1 BOTTLE (70710-1030-1)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103007

NDC 970710-1030
NDC 1070710-1030-7
NDC Item70710103007
Packaging28 CAPSULE in 1 BOTTLE (70710-1030-7)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167601

NDC 970771-1676
NDC 1070771-1676-1
NDC Item70771167601
Packaging100 CAPSULE in 1 BOTTLE (70771-1676-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167607

NDC 970771-1676
NDC 1070771-1676-7
NDC Item70771167607
Packaging28 CAPSULE in 1 BOTTLE (70771-1676-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069648

NDC 976282-696
NDC 1076282-696-48
NDC Item76282069648
Packaging28 CAPSULE in 1 BOTTLE (76282-696-48)
ANDAANDA214618
COLORTEXTBLUE(capsule blue green cap and White body)
ColorC48333 __
FDA SPL set id792335
Imprint codeCipla;2;5mg;cap;604;body
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-06-10
Marketing statusactive
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193501

NDC 90378-1935
NDC 100378-1935-01
NDC Item00378193501
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-01)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193528

NDC 90378-1935
NDC 100378-1935-28
NDC Item00378193528
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-28)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00480124128

NDC 90480-1241
NDC 100480-1241-28
NDC Item00480124128
Packaging28 CAPSULE in 1 BOTTLE (0480-1241-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id782674
Imprint codeNAT;2;5mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-08
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 31722025701

NDC 931722-257
NDC 1031722-257-01
NDC Item31722025701
Packaging100 CAPSULE in 1 BOTTLE (31722-257-01)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 31722025728

NDC 931722-257
NDC 1031722-257-28
NDC Item31722025728
Packaging28 CAPSULE in 1 BOTTLE (31722-257-28)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 43598051601

NDC 943598-516
NDC 1043598-516-01
NDC Item43598051601
Packaging100 CAPSULE in 1 BOTTLE (43598-516-01)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051663

NDC 943598-516
NDC 1043598-516-63
NDC Item43598051663
Packaging28 CAPSULE in 1 BOTTLE (43598-516-63)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048301

NDC 947781-483
NDC 1047781-483-01
NDC Item47781048301
Packaging100 CAPSULE in 1 BOTTLE (47781-483-01)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048328

NDC 947781-483
NDC 1047781-483-28
NDC Item47781048328
Packaging28 CAPSULE in 1 BOTTLE (47781-483-28)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034201

NDC 959651-342
NDC 1059651-342-01
NDC Item59651034201
Packaging100 CAPSULE in 1 BOTTLE (59651-342-01)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034207

NDC 959651-342
NDC 1059651-342-07
NDC Item59651034207
Packaging1 BLISTER PACK in 1 CARTON (59651-342-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034228

NDC 959651-342
NDC 1059651-342-28
NDC Item59651034228
Packaging28 CAPSULE in 1 BOTTLE (59651-342-28)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453202

NDC 960505-4532
NDC 1060505-4532-2
NDC Item60505453202
Packaging28 CAPSULE in 1 BOTTLE (60505-4532-2)
ANDAANDA211022
COLORTEXTWHITE(Opaque),BLUE(Blue green opaque)
ColorC48325;C48333 __
FDA SPL set id707296
Imprint codeAPO;L;2;5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004101

NDC 963304-041
NDC 1063304-041-01
NDC Item63304004101
Packaging100 CAPSULE in 1 BOTTLE (63304-041-01)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004127

NDC 963304-041
NDC 1063304-041-27
NDC Item63304004127
Packaging28 CAPSULE in 1 BOTTLE (63304-041-27)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 69097060473

NDC 969097-604
NDC 1069097-604-73
NDC Item69097060473
Packaging28 CAPSULE in 1 BOTTLE (69097-604-73)
ANDAANDA214618
COLORTEXTBLUE(blue green cap),WHITE(white body)
ColorC48333;C48325 __
FDA SPL set id699517
Imprint codeCipla;2;5mg;604
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 70710103001

NDC 970710-1030
NDC 1070710-1030-1
NDC Item70710103001
Packaging100 CAPSULE in 1 BOTTLE (70710-1030-1)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103007

NDC 970710-1030
NDC 1070710-1030-7
NDC Item70710103007
Packaging28 CAPSULE in 1 BOTTLE (70710-1030-7)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167601

NDC 970771-1676
NDC 1070771-1676-1
NDC Item70771167601
Packaging100 CAPSULE in 1 BOTTLE (70771-1676-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167607

NDC 970771-1676
NDC 1070771-1676-7
NDC Item70771167607
Packaging28 CAPSULE in 1 BOTTLE (70771-1676-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069648

NDC 976282-696
NDC 1076282-696-48
NDC Item76282069648
Packaging28 CAPSULE in 1 BOTTLE (76282-696-48)
ANDAANDA214618
COLORTEXTBLUE(capsule blue green cap and White body)
ColorC48333 __
FDA SPL set id792335
Imprint codeCipla;2;5mg;cap;604;body
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-06-10
Marketing statusactive
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193501

NDC 90378-1935
NDC 100378-1935-01
NDC Item00378193501
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-01)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193528

NDC 90378-1935
NDC 100378-1935-28
NDC Item00378193528
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-28)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00480124128

NDC 90480-1241
NDC 100480-1241-28
NDC Item00480124128
Packaging28 CAPSULE in 1 BOTTLE (0480-1241-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id782674
Imprint codeNAT;2;5mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-08
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 31722025701

NDC 931722-257
NDC 1031722-257-01
NDC Item31722025701
Packaging100 CAPSULE in 1 BOTTLE (31722-257-01)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 31722025728

NDC 931722-257
NDC 1031722-257-28
NDC Item31722025728
Packaging28 CAPSULE in 1 BOTTLE (31722-257-28)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 43598051601

NDC 943598-516
NDC 1043598-516-01
NDC Item43598051601
Packaging100 CAPSULE in 1 BOTTLE (43598-516-01)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051663

NDC 943598-516
NDC 1043598-516-63
NDC Item43598051663
Packaging28 CAPSULE in 1 BOTTLE (43598-516-63)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048301

NDC 947781-483
NDC 1047781-483-01
NDC Item47781048301
Packaging100 CAPSULE in 1 BOTTLE (47781-483-01)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048328

NDC 947781-483
NDC 1047781-483-28
NDC Item47781048328
Packaging28 CAPSULE in 1 BOTTLE (47781-483-28)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034201

NDC 959651-342
NDC 1059651-342-01
NDC Item59651034201
Packaging100 CAPSULE in 1 BOTTLE (59651-342-01)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034207

NDC 959651-342
NDC 1059651-342-07
NDC Item59651034207
Packaging1 BLISTER PACK in 1 CARTON (59651-342-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034228

NDC 959651-342
NDC 1059651-342-28
NDC Item59651034228
Packaging28 CAPSULE in 1 BOTTLE (59651-342-28)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453202

NDC 960505-4532
NDC 1060505-4532-2
NDC Item60505453202
Packaging28 CAPSULE in 1 BOTTLE (60505-4532-2)
ANDAANDA211022
COLORTEXTWHITE(Opaque),BLUE(Blue green opaque)
ColorC48325;C48333 __
FDA SPL set id707296
Imprint codeAPO;L;2;5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004101

NDC 963304-041
NDC 1063304-041-01
NDC Item63304004101
Packaging100 CAPSULE in 1 BOTTLE (63304-041-01)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004127

NDC 963304-041
NDC 1063304-041-27
NDC Item63304004127
Packaging28 CAPSULE in 1 BOTTLE (63304-041-27)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 69097060473

NDC 969097-604
NDC 1069097-604-73
NDC Item69097060473
Packaging28 CAPSULE in 1 BOTTLE (69097-604-73)
ANDAANDA214618
COLORTEXTBLUE(blue green cap),WHITE(white body)
ColorC48333;C48325 __
FDA SPL set id699517
Imprint codeCipla;2;5mg;604
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 70710103001

NDC 970710-1030
NDC 1070710-1030-1
NDC Item70710103001
Packaging100 CAPSULE in 1 BOTTLE (70710-1030-1)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103007

NDC 970710-1030
NDC 1070710-1030-7
NDC Item70710103007
Packaging28 CAPSULE in 1 BOTTLE (70710-1030-7)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167601

NDC 970771-1676
NDC 1070771-1676-1
NDC Item70771167601
Packaging100 CAPSULE in 1 BOTTLE (70771-1676-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167607

NDC 970771-1676
NDC 1070771-1676-7
NDC Item70771167607
Packaging28 CAPSULE in 1 BOTTLE (70771-1676-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069648

NDC 976282-696
NDC 1076282-696-48
NDC Item76282069648
Packaging28 CAPSULE in 1 BOTTLE (76282-696-48)
ANDAANDA214618
COLORTEXTBLUE(capsule blue green cap and White body)
ColorC48333 __
FDA SPL set id792335
Imprint codeCipla;2;5mg;cap;604;body
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-06-10
Marketing statusactive
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193501

NDC 90378-1935
NDC 100378-1935-01
NDC Item00378193501
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-01)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193528

NDC 90378-1935
NDC 100378-1935-28
NDC Item00378193528
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-28)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00480124128

NDC 90480-1241
NDC 100480-1241-28
NDC Item00480124128
Packaging28 CAPSULE in 1 BOTTLE (0480-1241-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id782674
Imprint codeNAT;2;5mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-08
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 31722025701

NDC 931722-257
NDC 1031722-257-01
NDC Item31722025701
Packaging100 CAPSULE in 1 BOTTLE (31722-257-01)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 31722025728

NDC 931722-257
NDC 1031722-257-28
NDC Item31722025728
Packaging28 CAPSULE in 1 BOTTLE (31722-257-28)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 43598051601

NDC 943598-516
NDC 1043598-516-01
NDC Item43598051601
Packaging100 CAPSULE in 1 BOTTLE (43598-516-01)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051663

NDC 943598-516
NDC 1043598-516-63
NDC Item43598051663
Packaging28 CAPSULE in 1 BOTTLE (43598-516-63)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048301

NDC 947781-483
NDC 1047781-483-01
NDC Item47781048301
Packaging100 CAPSULE in 1 BOTTLE (47781-483-01)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048328

NDC 947781-483
NDC 1047781-483-28
NDC Item47781048328
Packaging28 CAPSULE in 1 BOTTLE (47781-483-28)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034201

NDC 959651-342
NDC 1059651-342-01
NDC Item59651034201
Packaging100 CAPSULE in 1 BOTTLE (59651-342-01)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034207

NDC 959651-342
NDC 1059651-342-07
NDC Item59651034207
Packaging1 BLISTER PACK in 1 CARTON (59651-342-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034228

NDC 959651-342
NDC 1059651-342-28
NDC Item59651034228
Packaging28 CAPSULE in 1 BOTTLE (59651-342-28)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453202

NDC 960505-4532
NDC 1060505-4532-2
NDC Item60505453202
Packaging28 CAPSULE in 1 BOTTLE (60505-4532-2)
ANDAANDA211022
COLORTEXTWHITE(Opaque),BLUE(Blue green opaque)
ColorC48325;C48333 __
FDA SPL set id707296
Imprint codeAPO;L;2;5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004101

NDC 963304-041
NDC 1063304-041-01
NDC Item63304004101
Packaging100 CAPSULE in 1 BOTTLE (63304-041-01)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004127

NDC 963304-041
NDC 1063304-041-27
NDC Item63304004127
Packaging28 CAPSULE in 1 BOTTLE (63304-041-27)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 69097060473

NDC 969097-604
NDC 1069097-604-73
NDC Item69097060473
Packaging28 CAPSULE in 1 BOTTLE (69097-604-73)
ANDAANDA214618
COLORTEXTBLUE(blue green cap),WHITE(white body)
ColorC48333;C48325 __
FDA SPL set id699517
Imprint codeCipla;2;5mg;604
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 70710103001

NDC 970710-1030
NDC 1070710-1030-1
NDC Item70710103001
Packaging100 CAPSULE in 1 BOTTLE (70710-1030-1)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103007

NDC 970710-1030
NDC 1070710-1030-7
NDC Item70710103007
Packaging28 CAPSULE in 1 BOTTLE (70710-1030-7)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167601

NDC 970771-1676
NDC 1070771-1676-1
NDC Item70771167601
Packaging100 CAPSULE in 1 BOTTLE (70771-1676-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167607

NDC 970771-1676
NDC 1070771-1676-7
NDC Item70771167607
Packaging28 CAPSULE in 1 BOTTLE (70771-1676-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069648

NDC 976282-696
NDC 1076282-696-48
NDC Item76282069648
Packaging28 CAPSULE in 1 BOTTLE (76282-696-48)
ANDAANDA214618
COLORTEXTBLUE(capsule blue green cap and White body)
ColorC48333 __
FDA SPL set id792335
Imprint codeCipla;2;5mg;cap;604;body
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-06-10
Marketing statusactive
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193501

NDC 90378-1935
NDC 100378-1935-01
NDC Item00378193501
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-01)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193528

NDC 90378-1935
NDC 100378-1935-28
NDC Item00378193528
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-28)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00480124128

NDC 90480-1241
NDC 100480-1241-28
NDC Item00480124128
Packaging28 CAPSULE in 1 BOTTLE (0480-1241-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id782674
Imprint codeNAT;2;5mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-08
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 31722025701

NDC 931722-257
NDC 1031722-257-01
NDC Item31722025701
Packaging100 CAPSULE in 1 BOTTLE (31722-257-01)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 31722025728

NDC 931722-257
NDC 1031722-257-28
NDC Item31722025728
Packaging28 CAPSULE in 1 BOTTLE (31722-257-28)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 43598051601

NDC 943598-516
NDC 1043598-516-01
NDC Item43598051601
Packaging100 CAPSULE in 1 BOTTLE (43598-516-01)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051663

NDC 943598-516
NDC 1043598-516-63
NDC Item43598051663
Packaging28 CAPSULE in 1 BOTTLE (43598-516-63)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048301

NDC 947781-483
NDC 1047781-483-01
NDC Item47781048301
Packaging100 CAPSULE in 1 BOTTLE (47781-483-01)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048328

NDC 947781-483
NDC 1047781-483-28
NDC Item47781048328
Packaging28 CAPSULE in 1 BOTTLE (47781-483-28)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034201

NDC 959651-342
NDC 1059651-342-01
NDC Item59651034201
Packaging100 CAPSULE in 1 BOTTLE (59651-342-01)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034207

NDC 959651-342
NDC 1059651-342-07
NDC Item59651034207
Packaging1 BLISTER PACK in 1 CARTON (59651-342-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034228

NDC 959651-342
NDC 1059651-342-28
NDC Item59651034228
Packaging28 CAPSULE in 1 BOTTLE (59651-342-28)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453202

NDC 960505-4532
NDC 1060505-4532-2
NDC Item60505453202
Packaging28 CAPSULE in 1 BOTTLE (60505-4532-2)
ANDAANDA211022
COLORTEXTWHITE(Opaque),BLUE(Blue green opaque)
ColorC48325;C48333 __
FDA SPL set id707296
Imprint codeAPO;L;2;5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004101

NDC 963304-041
NDC 1063304-041-01
NDC Item63304004101
Packaging100 CAPSULE in 1 BOTTLE (63304-041-01)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004127

NDC 963304-041
NDC 1063304-041-27
NDC Item63304004127
Packaging28 CAPSULE in 1 BOTTLE (63304-041-27)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 69097060473

NDC 969097-604
NDC 1069097-604-73
NDC Item69097060473
Packaging28 CAPSULE in 1 BOTTLE (69097-604-73)
ANDAANDA214618
COLORTEXTBLUE(blue green cap),WHITE(white body)
ColorC48333;C48325 __
FDA SPL set id699517
Imprint codeCipla;2;5mg;604
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 70710103001

NDC 970710-1030
NDC 1070710-1030-1
NDC Item70710103001
Packaging100 CAPSULE in 1 BOTTLE (70710-1030-1)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103007

NDC 970710-1030
NDC 1070710-1030-7
NDC Item70710103007
Packaging28 CAPSULE in 1 BOTTLE (70710-1030-7)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167601

NDC 970771-1676
NDC 1070771-1676-1
NDC Item70771167601
Packaging100 CAPSULE in 1 BOTTLE (70771-1676-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167607

NDC 970771-1676
NDC 1070771-1676-7
NDC Item70771167607
Packaging28 CAPSULE in 1 BOTTLE (70771-1676-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069648

NDC 976282-696
NDC 1076282-696-48
NDC Item76282069648
Packaging28 CAPSULE in 1 BOTTLE (76282-696-48)
ANDAANDA214618
COLORTEXTBLUE(capsule blue green cap and White body)
ColorC48333 __
FDA SPL set id792335
Imprint codeCipla;2;5mg;cap;604;body
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-06-10
Marketing statusactive
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193501

NDC 90378-1935
NDC 100378-1935-01
NDC Item00378193501
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-01)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193528

NDC 90378-1935
NDC 100378-1935-28
NDC Item00378193528
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-28)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00480124128

NDC 90480-1241
NDC 100480-1241-28
NDC Item00480124128
Packaging28 CAPSULE in 1 BOTTLE (0480-1241-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id782674
Imprint codeNAT;2;5mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-08
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 31722025701

NDC 931722-257
NDC 1031722-257-01
NDC Item31722025701
Packaging100 CAPSULE in 1 BOTTLE (31722-257-01)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 31722025728

NDC 931722-257
NDC 1031722-257-28
NDC Item31722025728
Packaging28 CAPSULE in 1 BOTTLE (31722-257-28)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 43598051601

NDC 943598-516
NDC 1043598-516-01
NDC Item43598051601
Packaging100 CAPSULE in 1 BOTTLE (43598-516-01)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051663

NDC 943598-516
NDC 1043598-516-63
NDC Item43598051663
Packaging28 CAPSULE in 1 BOTTLE (43598-516-63)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048301

NDC 947781-483
NDC 1047781-483-01
NDC Item47781048301
Packaging100 CAPSULE in 1 BOTTLE (47781-483-01)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048328

NDC 947781-483
NDC 1047781-483-28
NDC Item47781048328
Packaging28 CAPSULE in 1 BOTTLE (47781-483-28)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034201

NDC 959651-342
NDC 1059651-342-01
NDC Item59651034201
Packaging100 CAPSULE in 1 BOTTLE (59651-342-01)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 59651-342

NDC Item 59651034207

NDC 959651-342
NDC 1059651-342-07
NDC Item59651034207
Packaging1 BLISTER PACK in 1 CARTON (59651-342-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034228

NDC 959651-342
NDC 1059651-342-28
NDC Item59651034228
Packaging28 CAPSULE in 1 BOTTLE (59651-342-28)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453202

NDC 960505-4532
NDC 1060505-4532-2
NDC Item60505453202
Packaging28 CAPSULE in 1 BOTTLE (60505-4532-2)
ANDAANDA211022
COLORTEXTWHITE(Opaque),BLUE(Blue green opaque)
ColorC48325;C48333 __
FDA SPL set id707296
Imprint codeAPO;L;2;5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004101

NDC 963304-041
NDC 1063304-041-01
NDC Item63304004101
Packaging100 CAPSULE in 1 BOTTLE (63304-041-01)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004127

NDC 963304-041
NDC 1063304-041-27
NDC Item63304004127
Packaging28 CAPSULE in 1 BOTTLE (63304-041-27)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 69097060473

NDC 969097-604
NDC 1069097-604-73
NDC Item69097060473
Packaging28 CAPSULE in 1 BOTTLE (69097-604-73)
ANDAANDA214618
COLORTEXTBLUE(blue green cap),WHITE(white body)
ColorC48333;C48325 __
FDA SPL set id699517
Imprint codeCipla;2;5mg;604
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 70710103001

NDC 970710-1030
NDC 1070710-1030-1
NDC Item70710103001
Packaging100 CAPSULE in 1 BOTTLE (70710-1030-1)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103007

NDC 970710-1030
NDC 1070710-1030-7
NDC Item70710103007
Packaging28 CAPSULE in 1 BOTTLE (70710-1030-7)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167601

NDC 970771-1676
NDC 1070771-1676-1
NDC Item70771167601
Packaging100 CAPSULE in 1 BOTTLE (70771-1676-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167607

NDC 970771-1676
NDC 1070771-1676-7
NDC Item70771167607
Packaging28 CAPSULE in 1 BOTTLE (70771-1676-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069648

NDC 976282-696
NDC 1076282-696-48
NDC Item76282069648
Packaging28 CAPSULE in 1 BOTTLE (76282-696-48)
ANDAANDA214618
COLORTEXTBLUE(capsule blue green cap and White body)
ColorC48333 __
FDA SPL set id792335
Imprint codeCipla;2;5mg;cap;604;body
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-06-10
Marketing statusactive
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193501

NDC 90378-1935
NDC 100378-1935-01
NDC Item00378193501
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-01)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193528

NDC 90378-1935
NDC 100378-1935-28
NDC Item00378193528
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-28)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00480124128

NDC 90480-1241
NDC 100480-1241-28
NDC Item00480124128
Packaging28 CAPSULE in 1 BOTTLE (0480-1241-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id782674
Imprint codeNAT;2;5mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-08
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 31722025701

NDC 931722-257
NDC 1031722-257-01
NDC Item31722025701
Packaging100 CAPSULE in 1 BOTTLE (31722-257-01)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 31722025728

NDC 931722-257
NDC 1031722-257-28
NDC Item31722025728
Packaging28 CAPSULE in 1 BOTTLE (31722-257-28)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 43598051601

NDC 943598-516
NDC 1043598-516-01
NDC Item43598051601
Packaging100 CAPSULE in 1 BOTTLE (43598-516-01)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051663

NDC 943598-516
NDC 1043598-516-63
NDC Item43598051663
Packaging28 CAPSULE in 1 BOTTLE (43598-516-63)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048301

NDC 947781-483
NDC 1047781-483-01
NDC Item47781048301
Packaging100 CAPSULE in 1 BOTTLE (47781-483-01)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048328

NDC 947781-483
NDC 1047781-483-28
NDC Item47781048328
Packaging28 CAPSULE in 1 BOTTLE (47781-483-28)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034201

NDC 959651-342
NDC 1059651-342-01
NDC Item59651034201
Packaging100 CAPSULE in 1 BOTTLE (59651-342-01)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034207

NDC 959651-342
NDC 1059651-342-07
NDC Item59651034207
Packaging1 BLISTER PACK in 1 CARTON (59651-342-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034228

NDC 959651-342
NDC 1059651-342-28
NDC Item59651034228
Packaging28 CAPSULE in 1 BOTTLE (59651-342-28)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453202

NDC 960505-4532
NDC 1060505-4532-2
NDC Item60505453202
Packaging28 CAPSULE in 1 BOTTLE (60505-4532-2)
ANDAANDA211022
COLORTEXTWHITE(Opaque),BLUE(Blue green opaque)
ColorC48325;C48333 __
FDA SPL set id707296
Imprint codeAPO;L;2;5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004101

NDC 963304-041
NDC 1063304-041-01
NDC Item63304004101
Packaging100 CAPSULE in 1 BOTTLE (63304-041-01)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004127

NDC 963304-041
NDC 1063304-041-27
NDC Item63304004127
Packaging28 CAPSULE in 1 BOTTLE (63304-041-27)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 69097060473

NDC 969097-604
NDC 1069097-604-73
NDC Item69097060473
Packaging28 CAPSULE in 1 BOTTLE (69097-604-73)
ANDAANDA214618
COLORTEXTBLUE(blue green cap),WHITE(white body)
ColorC48333;C48325 __
FDA SPL set id699517
Imprint codeCipla;2;5mg;604
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 70710103001

NDC 970710-1030
NDC 1070710-1030-1
NDC Item70710103001
Packaging100 CAPSULE in 1 BOTTLE (70710-1030-1)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103007

NDC 970710-1030
NDC 1070710-1030-7
NDC Item70710103007
Packaging28 CAPSULE in 1 BOTTLE (70710-1030-7)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167601

NDC 970771-1676
NDC 1070771-1676-1
NDC Item70771167601
Packaging100 CAPSULE in 1 BOTTLE (70771-1676-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167607

NDC 970771-1676
NDC 1070771-1676-7
NDC Item70771167607
Packaging28 CAPSULE in 1 BOTTLE (70771-1676-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069648

NDC 976282-696
NDC 1076282-696-48
NDC Item76282069648
Packaging28 CAPSULE in 1 BOTTLE (76282-696-48)
ANDAANDA214618
COLORTEXTBLUE(capsule blue green cap and White body)
ColorC48333 __
FDA SPL set id792335
Imprint codeCipla;2;5mg;cap;604;body
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-06-10
Marketing statusactive
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193501

NDC 90378-1935
NDC 100378-1935-01
NDC Item00378193501
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-01)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193528

NDC 90378-1935
NDC 100378-1935-28
NDC Item00378193528
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-28)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00480124128

NDC 90480-1241
NDC 100480-1241-28
NDC Item00480124128
Packaging28 CAPSULE in 1 BOTTLE (0480-1241-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id782674
Imprint codeNAT;2;5mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-08
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 31722025701

NDC 931722-257
NDC 1031722-257-01
NDC Item31722025701
Packaging100 CAPSULE in 1 BOTTLE (31722-257-01)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 31722025728

NDC 931722-257
NDC 1031722-257-28
NDC Item31722025728
Packaging28 CAPSULE in 1 BOTTLE (31722-257-28)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 43598051601

NDC 943598-516
NDC 1043598-516-01
NDC Item43598051601
Packaging100 CAPSULE in 1 BOTTLE (43598-516-01)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051663

NDC 943598-516
NDC 1043598-516-63
NDC Item43598051663
Packaging28 CAPSULE in 1 BOTTLE (43598-516-63)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048301

NDC 947781-483
NDC 1047781-483-01
NDC Item47781048301
Packaging100 CAPSULE in 1 BOTTLE (47781-483-01)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048328

NDC 947781-483
NDC 1047781-483-28
NDC Item47781048328
Packaging28 CAPSULE in 1 BOTTLE (47781-483-28)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034201

NDC 959651-342
NDC 1059651-342-01
NDC Item59651034201
Packaging100 CAPSULE in 1 BOTTLE (59651-342-01)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 59651-342

NDC Item 59651034207

NDC 959651-342
NDC 1059651-342-07
NDC Item59651034207
Packaging1 BLISTER PACK in 1 CARTON (59651-342-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034228

NDC 959651-342
NDC 1059651-342-28
NDC Item59651034228
Packaging28 CAPSULE in 1 BOTTLE (59651-342-28)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453202

NDC 960505-4532
NDC 1060505-4532-2
NDC Item60505453202
Packaging28 CAPSULE in 1 BOTTLE (60505-4532-2)
ANDAANDA211022
COLORTEXTWHITE(Opaque),BLUE(Blue green opaque)
ColorC48325;C48333 __
FDA SPL set id707296
Imprint codeAPO;L;2;5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004101

NDC 963304-041
NDC 1063304-041-01
NDC Item63304004101
Packaging100 CAPSULE in 1 BOTTLE (63304-041-01)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004127

NDC 963304-041
NDC 1063304-041-27
NDC Item63304004127
Packaging28 CAPSULE in 1 BOTTLE (63304-041-27)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 69097060473

NDC 969097-604
NDC 1069097-604-73
NDC Item69097060473
Packaging28 CAPSULE in 1 BOTTLE (69097-604-73)
ANDAANDA214618
COLORTEXTBLUE(blue green cap),WHITE(white body)
ColorC48333;C48325 __
FDA SPL set id699517
Imprint codeCipla;2;5mg;604
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 70710103001

NDC 970710-1030
NDC 1070710-1030-1
NDC Item70710103001
Packaging100 CAPSULE in 1 BOTTLE (70710-1030-1)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103007

NDC 970710-1030
NDC 1070710-1030-7
NDC Item70710103007
Packaging28 CAPSULE in 1 BOTTLE (70710-1030-7)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167601

NDC 970771-1676
NDC 1070771-1676-1
NDC Item70771167601
Packaging100 CAPSULE in 1 BOTTLE (70771-1676-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167607

NDC 970771-1676
NDC 1070771-1676-7
NDC Item70771167607
Packaging28 CAPSULE in 1 BOTTLE (70771-1676-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069648

NDC 976282-696
NDC 1076282-696-48
NDC Item76282069648
Packaging28 CAPSULE in 1 BOTTLE (76282-696-48)
ANDAANDA214618
COLORTEXTBLUE(capsule blue green cap and White body)
ColorC48333 __
FDA SPL set id792335
Imprint codeCipla;2;5mg;cap;604;body
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-06-10
Marketing statusactive
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193501

NDC 90378-1935
NDC 100378-1935-01
NDC Item00378193501
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-01)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193528

NDC 90378-1935
NDC 100378-1935-28
NDC Item00378193528
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-28)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00480124128

NDC 90480-1241
NDC 100480-1241-28
NDC Item00480124128
Packaging28 CAPSULE in 1 BOTTLE (0480-1241-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id782674
Imprint codeNAT;2;5mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-08
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 31722025701

NDC 931722-257
NDC 1031722-257-01
NDC Item31722025701
Packaging100 CAPSULE in 1 BOTTLE (31722-257-01)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 31722025728

NDC 931722-257
NDC 1031722-257-28
NDC Item31722025728
Packaging28 CAPSULE in 1 BOTTLE (31722-257-28)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 43598051601

NDC 943598-516
NDC 1043598-516-01
NDC Item43598051601
Packaging100 CAPSULE in 1 BOTTLE (43598-516-01)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051663

NDC 943598-516
NDC 1043598-516-63
NDC Item43598051663
Packaging28 CAPSULE in 1 BOTTLE (43598-516-63)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048301

NDC 947781-483
NDC 1047781-483-01
NDC Item47781048301
Packaging100 CAPSULE in 1 BOTTLE (47781-483-01)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048328

NDC 947781-483
NDC 1047781-483-28
NDC Item47781048328
Packaging28 CAPSULE in 1 BOTTLE (47781-483-28)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034201

NDC 959651-342
NDC 1059651-342-01
NDC Item59651034201
Packaging100 CAPSULE in 1 BOTTLE (59651-342-01)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034207

NDC 959651-342
NDC 1059651-342-07
NDC Item59651034207
Packaging1 BLISTER PACK in 1 CARTON (59651-342-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034228

NDC 959651-342
NDC 1059651-342-28
NDC Item59651034228
Packaging28 CAPSULE in 1 BOTTLE (59651-342-28)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453202

NDC 960505-4532
NDC 1060505-4532-2
NDC Item60505453202
Packaging28 CAPSULE in 1 BOTTLE (60505-4532-2)
ANDAANDA211022
COLORTEXTWHITE(Opaque),BLUE(Blue green opaque)
ColorC48325;C48333 __
FDA SPL set id707296
Imprint codeAPO;L;2;5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004101

NDC 963304-041
NDC 1063304-041-01
NDC Item63304004101
Packaging100 CAPSULE in 1 BOTTLE (63304-041-01)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004127

NDC 963304-041
NDC 1063304-041-27
NDC Item63304004127
Packaging28 CAPSULE in 1 BOTTLE (63304-041-27)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 69097060473

NDC 969097-604
NDC 1069097-604-73
NDC Item69097060473
Packaging28 CAPSULE in 1 BOTTLE (69097-604-73)
ANDAANDA214618
COLORTEXTBLUE(blue green cap),WHITE(white body)
ColorC48333;C48325 __
FDA SPL set id699517
Imprint codeCipla;2;5mg;604
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 70710103001

NDC 970710-1030
NDC 1070710-1030-1
NDC Item70710103001
Packaging100 CAPSULE in 1 BOTTLE (70710-1030-1)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103007

NDC 970710-1030
NDC 1070710-1030-7
NDC Item70710103007
Packaging28 CAPSULE in 1 BOTTLE (70710-1030-7)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167601

NDC 970771-1676
NDC 1070771-1676-1
NDC Item70771167601
Packaging100 CAPSULE in 1 BOTTLE (70771-1676-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167607

NDC 970771-1676
NDC 1070771-1676-7
NDC Item70771167607
Packaging28 CAPSULE in 1 BOTTLE (70771-1676-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069648

NDC 976282-696
NDC 1076282-696-48
NDC Item76282069648
Packaging28 CAPSULE in 1 BOTTLE (76282-696-48)
ANDAANDA214618
COLORTEXTBLUE(capsule blue green cap and White body)
ColorC48333 __
FDA SPL set id792335
Imprint codeCipla;2;5mg;cap;604;body
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-06-10
Marketing statusactive
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193501

NDC 90378-1935
NDC 100378-1935-01
NDC Item00378193501
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-01)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193528

NDC 90378-1935
NDC 100378-1935-28
NDC Item00378193528
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-28)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00480124128

NDC 90480-1241
NDC 100480-1241-28
NDC Item00480124128
Packaging28 CAPSULE in 1 BOTTLE (0480-1241-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id782674
Imprint codeNAT;2;5mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-08
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 31722025701

NDC 931722-257
NDC 1031722-257-01
NDC Item31722025701
Packaging100 CAPSULE in 1 BOTTLE (31722-257-01)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 31722025728

NDC 931722-257
NDC 1031722-257-28
NDC Item31722025728
Packaging28 CAPSULE in 1 BOTTLE (31722-257-28)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 43598051601

NDC 943598-516
NDC 1043598-516-01
NDC Item43598051601
Packaging100 CAPSULE in 1 BOTTLE (43598-516-01)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051663

NDC 943598-516
NDC 1043598-516-63
NDC Item43598051663
Packaging28 CAPSULE in 1 BOTTLE (43598-516-63)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048301

NDC 947781-483
NDC 1047781-483-01
NDC Item47781048301
Packaging100 CAPSULE in 1 BOTTLE (47781-483-01)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048328

NDC 947781-483
NDC 1047781-483-28
NDC Item47781048328
Packaging28 CAPSULE in 1 BOTTLE (47781-483-28)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034201

NDC 959651-342
NDC 1059651-342-01
NDC Item59651034201
Packaging100 CAPSULE in 1 BOTTLE (59651-342-01)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034207

NDC 959651-342
NDC 1059651-342-07
NDC Item59651034207
Packaging1 BLISTER PACK in 1 CARTON (59651-342-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034228

NDC 959651-342
NDC 1059651-342-28
NDC Item59651034228
Packaging28 CAPSULE in 1 BOTTLE (59651-342-28)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453202

NDC 960505-4532
NDC 1060505-4532-2
NDC Item60505453202
Packaging28 CAPSULE in 1 BOTTLE (60505-4532-2)
ANDAANDA211022
COLORTEXTWHITE(Opaque),BLUE(Blue green opaque)
ColorC48325;C48333 __
FDA SPL set id707296
Imprint codeAPO;L;2;5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004101

NDC 963304-041
NDC 1063304-041-01
NDC Item63304004101
Packaging100 CAPSULE in 1 BOTTLE (63304-041-01)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004127

NDC 963304-041
NDC 1063304-041-27
NDC Item63304004127
Packaging28 CAPSULE in 1 BOTTLE (63304-041-27)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 69097060473

NDC 969097-604
NDC 1069097-604-73
NDC Item69097060473
Packaging28 CAPSULE in 1 BOTTLE (69097-604-73)
ANDAANDA214618
COLORTEXTBLUE(blue green cap),WHITE(white body)
ColorC48333;C48325 __
FDA SPL set id699517
Imprint codeCipla;2;5mg;604
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 70710103001

NDC 970710-1030
NDC 1070710-1030-1
NDC Item70710103001
Packaging100 CAPSULE in 1 BOTTLE (70710-1030-1)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103007

NDC 970710-1030
NDC 1070710-1030-7
NDC Item70710103007
Packaging28 CAPSULE in 1 BOTTLE (70710-1030-7)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167601

NDC 970771-1676
NDC 1070771-1676-1
NDC Item70771167601
Packaging100 CAPSULE in 1 BOTTLE (70771-1676-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167607

NDC 970771-1676
NDC 1070771-1676-7
NDC Item70771167607
Packaging28 CAPSULE in 1 BOTTLE (70771-1676-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069648

NDC 976282-696
NDC 1076282-696-48
NDC Item76282069648
Packaging28 CAPSULE in 1 BOTTLE (76282-696-48)
ANDAANDA214618
COLORTEXTBLUE(capsule blue green cap and White body)
ColorC48333 __
FDA SPL set id792335
Imprint codeCipla;2;5mg;cap;604;body
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-06-10
Marketing statusactive
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193501

NDC 90378-1935
NDC 100378-1935-01
NDC Item00378193501
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-01)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193528

NDC 90378-1935
NDC 100378-1935-28
NDC Item00378193528
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-28)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00480124128

NDC 90480-1241
NDC 100480-1241-28
NDC Item00480124128
Packaging28 CAPSULE in 1 BOTTLE (0480-1241-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id782674
Imprint codeNAT;2;5mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-08
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 31722025701

NDC 931722-257
NDC 1031722-257-01
NDC Item31722025701
Packaging100 CAPSULE in 1 BOTTLE (31722-257-01)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 31722025728

NDC 931722-257
NDC 1031722-257-28
NDC Item31722025728
Packaging28 CAPSULE in 1 BOTTLE (31722-257-28)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 43598051601

NDC 943598-516
NDC 1043598-516-01
NDC Item43598051601
Packaging100 CAPSULE in 1 BOTTLE (43598-516-01)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051663

NDC 943598-516
NDC 1043598-516-63
NDC Item43598051663
Packaging28 CAPSULE in 1 BOTTLE (43598-516-63)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048301

NDC 947781-483
NDC 1047781-483-01
NDC Item47781048301
Packaging100 CAPSULE in 1 BOTTLE (47781-483-01)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048328

NDC 947781-483
NDC 1047781-483-28
NDC Item47781048328
Packaging28 CAPSULE in 1 BOTTLE (47781-483-28)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034201

NDC 959651-342
NDC 1059651-342-01
NDC Item59651034201
Packaging100 CAPSULE in 1 BOTTLE (59651-342-01)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034207

NDC 959651-342
NDC 1059651-342-07
NDC Item59651034207
Packaging1 BLISTER PACK in 1 CARTON (59651-342-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034228

NDC 959651-342
NDC 1059651-342-28
NDC Item59651034228
Packaging28 CAPSULE in 1 BOTTLE (59651-342-28)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453202

NDC 960505-4532
NDC 1060505-4532-2
NDC Item60505453202
Packaging28 CAPSULE in 1 BOTTLE (60505-4532-2)
ANDAANDA211022
COLORTEXTWHITE(Opaque),BLUE(Blue green opaque)
ColorC48325;C48333 __
FDA SPL set id707296
Imprint codeAPO;L;2;5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004101

NDC 963304-041
NDC 1063304-041-01
NDC Item63304004101
Packaging100 CAPSULE in 1 BOTTLE (63304-041-01)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004127

NDC 963304-041
NDC 1063304-041-27
NDC Item63304004127
Packaging28 CAPSULE in 1 BOTTLE (63304-041-27)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 69097060473

NDC 969097-604
NDC 1069097-604-73
NDC Item69097060473
Packaging28 CAPSULE in 1 BOTTLE (69097-604-73)
ANDAANDA214618
COLORTEXTBLUE(blue green cap),WHITE(white body)
ColorC48333;C48325 __
FDA SPL set id699517
Imprint codeCipla;2;5mg;604
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 70710103001

NDC 970710-1030
NDC 1070710-1030-1
NDC Item70710103001
Packaging100 CAPSULE in 1 BOTTLE (70710-1030-1)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103007

NDC 970710-1030
NDC 1070710-1030-7
NDC Item70710103007
Packaging28 CAPSULE in 1 BOTTLE (70710-1030-7)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167601

NDC 970771-1676
NDC 1070771-1676-1
NDC Item70771167601
Packaging100 CAPSULE in 1 BOTTLE (70771-1676-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167607

NDC 970771-1676
NDC 1070771-1676-7
NDC Item70771167607
Packaging28 CAPSULE in 1 BOTTLE (70771-1676-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069648

NDC 976282-696
NDC 1076282-696-48
NDC Item76282069648
Packaging28 CAPSULE in 1 BOTTLE (76282-696-48)
ANDAANDA214618
COLORTEXTBLUE(capsule blue green cap and White body)
ColorC48333 __
FDA SPL set id792335
Imprint codeCipla;2;5mg;cap;604;body
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-06-10
Marketing statusactive
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193501

NDC 90378-1935
NDC 100378-1935-01
NDC Item00378193501
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-01)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193528

NDC 90378-1935
NDC 100378-1935-28
NDC Item00378193528
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-28)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00480124128

NDC 90480-1241
NDC 100480-1241-28
NDC Item00480124128
Packaging28 CAPSULE in 1 BOTTLE (0480-1241-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id782674
Imprint codeNAT;2;5mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-08
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 31722025701

NDC 931722-257
NDC 1031722-257-01
NDC Item31722025701
Packaging100 CAPSULE in 1 BOTTLE (31722-257-01)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 31722025728

NDC 931722-257
NDC 1031722-257-28
NDC Item31722025728
Packaging28 CAPSULE in 1 BOTTLE (31722-257-28)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 43598051601

NDC 943598-516
NDC 1043598-516-01
NDC Item43598051601
Packaging100 CAPSULE in 1 BOTTLE (43598-516-01)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051663

NDC 943598-516
NDC 1043598-516-63
NDC Item43598051663
Packaging28 CAPSULE in 1 BOTTLE (43598-516-63)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048301

NDC 947781-483
NDC 1047781-483-01
NDC Item47781048301
Packaging100 CAPSULE in 1 BOTTLE (47781-483-01)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048328

NDC 947781-483
NDC 1047781-483-28
NDC Item47781048328
Packaging28 CAPSULE in 1 BOTTLE (47781-483-28)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034201

NDC 959651-342
NDC 1059651-342-01
NDC Item59651034201
Packaging100 CAPSULE in 1 BOTTLE (59651-342-01)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034207

NDC 959651-342
NDC 1059651-342-07
NDC Item59651034207
Packaging1 BLISTER PACK in 1 CARTON (59651-342-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034228

NDC 959651-342
NDC 1059651-342-28
NDC Item59651034228
Packaging28 CAPSULE in 1 BOTTLE (59651-342-28)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453202

NDC 960505-4532
NDC 1060505-4532-2
NDC Item60505453202
Packaging28 CAPSULE in 1 BOTTLE (60505-4532-2)
ANDAANDA211022
COLORTEXTWHITE(Opaque),BLUE(Blue green opaque)
ColorC48325;C48333 __
FDA SPL set id707296
Imprint codeAPO;L;2;5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004101

NDC 963304-041
NDC 1063304-041-01
NDC Item63304004101
Packaging100 CAPSULE in 1 BOTTLE (63304-041-01)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004127

NDC 963304-041
NDC 1063304-041-27
NDC Item63304004127
Packaging28 CAPSULE in 1 BOTTLE (63304-041-27)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 69097060473

NDC 969097-604
NDC 1069097-604-73
NDC Item69097060473
Packaging28 CAPSULE in 1 BOTTLE (69097-604-73)
ANDAANDA214618
COLORTEXTBLUE(blue green cap),WHITE(white body)
ColorC48333;C48325 __
FDA SPL set id699517
Imprint codeCipla;2;5mg;604
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 70710103001

NDC 970710-1030
NDC 1070710-1030-1
NDC Item70710103001
Packaging100 CAPSULE in 1 BOTTLE (70710-1030-1)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103007

NDC 970710-1030
NDC 1070710-1030-7
NDC Item70710103007
Packaging28 CAPSULE in 1 BOTTLE (70710-1030-7)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167601

NDC 970771-1676
NDC 1070771-1676-1
NDC Item70771167601
Packaging100 CAPSULE in 1 BOTTLE (70771-1676-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167607

NDC 970771-1676
NDC 1070771-1676-7
NDC Item70771167607
Packaging28 CAPSULE in 1 BOTTLE (70771-1676-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069648

NDC 976282-696
NDC 1076282-696-48
NDC Item76282069648
Packaging28 CAPSULE in 1 BOTTLE (76282-696-48)
ANDAANDA214618
COLORTEXTBLUE(capsule blue green cap and White body)
ColorC48333 __
FDA SPL set id792335
Imprint codeCipla;2;5mg;cap;604;body
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-06-10
Marketing statusactive
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193501

NDC 90378-1935
NDC 100378-1935-01
NDC Item00378193501
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-01)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193528

NDC 90378-1935
NDC 100378-1935-28
NDC Item00378193528
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-28)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00480124128

NDC 90480-1241
NDC 100480-1241-28
NDC Item00480124128
Packaging28 CAPSULE in 1 BOTTLE (0480-1241-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id782674
Imprint codeNAT;2;5mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-08
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 31722025701

NDC 931722-257
NDC 1031722-257-01
NDC Item31722025701
Packaging100 CAPSULE in 1 BOTTLE (31722-257-01)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 31722025728

NDC 931722-257
NDC 1031722-257-28
NDC Item31722025728
Packaging28 CAPSULE in 1 BOTTLE (31722-257-28)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 43598051601

NDC 943598-516
NDC 1043598-516-01
NDC Item43598051601
Packaging100 CAPSULE in 1 BOTTLE (43598-516-01)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051663

NDC 943598-516
NDC 1043598-516-63
NDC Item43598051663
Packaging28 CAPSULE in 1 BOTTLE (43598-516-63)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048301

NDC 947781-483
NDC 1047781-483-01
NDC Item47781048301
Packaging100 CAPSULE in 1 BOTTLE (47781-483-01)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048328

NDC 947781-483
NDC 1047781-483-28
NDC Item47781048328
Packaging28 CAPSULE in 1 BOTTLE (47781-483-28)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034201

NDC 959651-342
NDC 1059651-342-01
NDC Item59651034201
Packaging100 CAPSULE in 1 BOTTLE (59651-342-01)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034207

NDC 959651-342
NDC 1059651-342-07
NDC Item59651034207
Packaging1 BLISTER PACK in 1 CARTON (59651-342-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034228

NDC 959651-342
NDC 1059651-342-28
NDC Item59651034228
Packaging28 CAPSULE in 1 BOTTLE (59651-342-28)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453202

NDC 960505-4532
NDC 1060505-4532-2
NDC Item60505453202
Packaging28 CAPSULE in 1 BOTTLE (60505-4532-2)
ANDAANDA211022
COLORTEXTWHITE(Opaque),BLUE(Blue green opaque)
ColorC48325;C48333 __
FDA SPL set id707296
Imprint codeAPO;L;2;5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004101

NDC 963304-041
NDC 1063304-041-01
NDC Item63304004101
Packaging100 CAPSULE in 1 BOTTLE (63304-041-01)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004127

NDC 963304-041
NDC 1063304-041-27
NDC Item63304004127
Packaging28 CAPSULE in 1 BOTTLE (63304-041-27)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 69097060473

NDC 969097-604
NDC 1069097-604-73
NDC Item69097060473
Packaging28 CAPSULE in 1 BOTTLE (69097-604-73)
ANDAANDA214618
COLORTEXTBLUE(blue green cap),WHITE(white body)
ColorC48333;C48325 __
FDA SPL set id699517
Imprint codeCipla;2;5mg;604
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 70710103001

NDC 970710-1030
NDC 1070710-1030-1
NDC Item70710103001
Packaging100 CAPSULE in 1 BOTTLE (70710-1030-1)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103007

NDC 970710-1030
NDC 1070710-1030-7
NDC Item70710103007
Packaging28 CAPSULE in 1 BOTTLE (70710-1030-7)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167601

NDC 970771-1676
NDC 1070771-1676-1
NDC Item70771167601
Packaging100 CAPSULE in 1 BOTTLE (70771-1676-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167607

NDC 970771-1676
NDC 1070771-1676-7
NDC Item70771167607
Packaging28 CAPSULE in 1 BOTTLE (70771-1676-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069648

NDC 976282-696
NDC 1076282-696-48
NDC Item76282069648
Packaging28 CAPSULE in 1 BOTTLE (76282-696-48)
ANDAANDA214618
COLORTEXTBLUE(capsule blue green cap and White body)
ColorC48333 __
FDA SPL set id792335
Imprint codeCipla;2;5mg;cap;604;body
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-06-10
Marketing statusactive
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193501

NDC 90378-1935
NDC 100378-1935-01
NDC Item00378193501
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-01)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193528

NDC 90378-1935
NDC 100378-1935-28
NDC Item00378193528
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-28)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00480124128

NDC 90480-1241
NDC 100480-1241-28
NDC Item00480124128
Packaging28 CAPSULE in 1 BOTTLE (0480-1241-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id782674
Imprint codeNAT;2;5mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-08
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 31722025701

NDC 931722-257
NDC 1031722-257-01
NDC Item31722025701
Packaging100 CAPSULE in 1 BOTTLE (31722-257-01)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 31722025728

NDC 931722-257
NDC 1031722-257-28
NDC Item31722025728
Packaging28 CAPSULE in 1 BOTTLE (31722-257-28)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 43598051601

NDC 943598-516
NDC 1043598-516-01
NDC Item43598051601
Packaging100 CAPSULE in 1 BOTTLE (43598-516-01)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051663

NDC 943598-516
NDC 1043598-516-63
NDC Item43598051663
Packaging28 CAPSULE in 1 BOTTLE (43598-516-63)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048301

NDC 947781-483
NDC 1047781-483-01
NDC Item47781048301
Packaging100 CAPSULE in 1 BOTTLE (47781-483-01)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048328

NDC 947781-483
NDC 1047781-483-28
NDC Item47781048328
Packaging28 CAPSULE in 1 BOTTLE (47781-483-28)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034201

NDC 959651-342
NDC 1059651-342-01
NDC Item59651034201
Packaging100 CAPSULE in 1 BOTTLE (59651-342-01)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034207

NDC 959651-342
NDC 1059651-342-07
NDC Item59651034207
Packaging1 BLISTER PACK in 1 CARTON (59651-342-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034228

NDC 959651-342
NDC 1059651-342-28
NDC Item59651034228
Packaging28 CAPSULE in 1 BOTTLE (59651-342-28)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453202

NDC 960505-4532
NDC 1060505-4532-2
NDC Item60505453202
Packaging28 CAPSULE in 1 BOTTLE (60505-4532-2)
ANDAANDA211022
COLORTEXTWHITE(Opaque),BLUE(Blue green opaque)
ColorC48325;C48333 __
FDA SPL set id707296
Imprint codeAPO;L;2;5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004101

NDC 963304-041
NDC 1063304-041-01
NDC Item63304004101
Packaging100 CAPSULE in 1 BOTTLE (63304-041-01)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004127

NDC 963304-041
NDC 1063304-041-27
NDC Item63304004127
Packaging28 CAPSULE in 1 BOTTLE (63304-041-27)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 69097060473

NDC 969097-604
NDC 1069097-604-73
NDC Item69097060473
Packaging28 CAPSULE in 1 BOTTLE (69097-604-73)
ANDAANDA214618
COLORTEXTBLUE(blue green cap),WHITE(white body)
ColorC48333;C48325 __
FDA SPL set id699517
Imprint codeCipla;2;5mg;604
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 70710103001

NDC 970710-1030
NDC 1070710-1030-1
NDC Item70710103001
Packaging100 CAPSULE in 1 BOTTLE (70710-1030-1)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103007

NDC 970710-1030
NDC 1070710-1030-7
NDC Item70710103007
Packaging28 CAPSULE in 1 BOTTLE (70710-1030-7)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167601

NDC 970771-1676
NDC 1070771-1676-1
NDC Item70771167601
Packaging100 CAPSULE in 1 BOTTLE (70771-1676-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167607

NDC 970771-1676
NDC 1070771-1676-7
NDC Item70771167607
Packaging28 CAPSULE in 1 BOTTLE (70771-1676-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069648

NDC 976282-696
NDC 1076282-696-48
NDC Item76282069648
Packaging28 CAPSULE in 1 BOTTLE (76282-696-48)
ANDAANDA214618
COLORTEXTBLUE(capsule blue green cap and White body)
ColorC48333 __
FDA SPL set id792335
Imprint codeCipla;2;5mg;cap;604;body
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-06-10
Marketing statusactive
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193501

NDC 90378-1935
NDC 100378-1935-01
NDC Item00378193501
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-01)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193528

NDC 90378-1935
NDC 100378-1935-28
NDC Item00378193528
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-28)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00480124128

NDC 90480-1241
NDC 100480-1241-28
NDC Item00480124128
Packaging28 CAPSULE in 1 BOTTLE (0480-1241-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id782674
Imprint codeNAT;2;5mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-08
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 31722025701

NDC 931722-257
NDC 1031722-257-01
NDC Item31722025701
Packaging100 CAPSULE in 1 BOTTLE (31722-257-01)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 31722025728

NDC 931722-257
NDC 1031722-257-28
NDC Item31722025728
Packaging28 CAPSULE in 1 BOTTLE (31722-257-28)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 43598051601

NDC 943598-516
NDC 1043598-516-01
NDC Item43598051601
Packaging100 CAPSULE in 1 BOTTLE (43598-516-01)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051663

NDC 943598-516
NDC 1043598-516-63
NDC Item43598051663
Packaging28 CAPSULE in 1 BOTTLE (43598-516-63)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048301

NDC 947781-483
NDC 1047781-483-01
NDC Item47781048301
Packaging100 CAPSULE in 1 BOTTLE (47781-483-01)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048328

NDC 947781-483
NDC 1047781-483-28
NDC Item47781048328
Packaging28 CAPSULE in 1 BOTTLE (47781-483-28)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034201

NDC 959651-342
NDC 1059651-342-01
NDC Item59651034201
Packaging100 CAPSULE in 1 BOTTLE (59651-342-01)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034207

NDC 959651-342
NDC 1059651-342-07
NDC Item59651034207
Packaging1 BLISTER PACK in 1 CARTON (59651-342-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034228

NDC 959651-342
NDC 1059651-342-28
NDC Item59651034228
Packaging28 CAPSULE in 1 BOTTLE (59651-342-28)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453202

NDC 960505-4532
NDC 1060505-4532-2
NDC Item60505453202
Packaging28 CAPSULE in 1 BOTTLE (60505-4532-2)
ANDAANDA211022
COLORTEXTWHITE(Opaque),BLUE(Blue green opaque)
ColorC48325;C48333 __
FDA SPL set id707296
Imprint codeAPO;L;2;5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004101

NDC 963304-041
NDC 1063304-041-01
NDC Item63304004101
Packaging100 CAPSULE in 1 BOTTLE (63304-041-01)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004127

NDC 963304-041
NDC 1063304-041-27
NDC Item63304004127
Packaging28 CAPSULE in 1 BOTTLE (63304-041-27)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 69097060473

NDC 969097-604
NDC 1069097-604-73
NDC Item69097060473
Packaging28 CAPSULE in 1 BOTTLE (69097-604-73)
ANDAANDA214618
COLORTEXTBLUE(blue green cap),WHITE(white body)
ColorC48333;C48325 __
FDA SPL set id699517
Imprint codeCipla;2;5mg;604
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 70710103001

NDC 970710-1030
NDC 1070710-1030-1
NDC Item70710103001
Packaging100 CAPSULE in 1 BOTTLE (70710-1030-1)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103007

NDC 970710-1030
NDC 1070710-1030-7
NDC Item70710103007
Packaging28 CAPSULE in 1 BOTTLE (70710-1030-7)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167601

NDC 970771-1676
NDC 1070771-1676-1
NDC Item70771167601
Packaging100 CAPSULE in 1 BOTTLE (70771-1676-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167607

NDC 970771-1676
NDC 1070771-1676-7
NDC Item70771167607
Packaging28 CAPSULE in 1 BOTTLE (70771-1676-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069648

NDC 976282-696
NDC 1076282-696-48
NDC Item76282069648
Packaging28 CAPSULE in 1 BOTTLE (76282-696-48)
ANDAANDA214618
COLORTEXTBLUE(capsule blue green cap and White body)
ColorC48333 __
FDA SPL set id792335
Imprint codeCipla;2;5mg;cap;604;body
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-06-10
Marketing statusactive
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193501

NDC 90378-1935
NDC 100378-1935-01
NDC Item00378193501
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-01)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193528

NDC 90378-1935
NDC 100378-1935-28
NDC Item00378193528
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-28)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00480124128

NDC 90480-1241
NDC 100480-1241-28
NDC Item00480124128
Packaging28 CAPSULE in 1 BOTTLE (0480-1241-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id782674
Imprint codeNAT;2;5mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-08
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 31722025701

NDC 931722-257
NDC 1031722-257-01
NDC Item31722025701
Packaging100 CAPSULE in 1 BOTTLE (31722-257-01)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 31722025728

NDC 931722-257
NDC 1031722-257-28
NDC Item31722025728
Packaging28 CAPSULE in 1 BOTTLE (31722-257-28)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 43598051601

NDC 943598-516
NDC 1043598-516-01
NDC Item43598051601
Packaging100 CAPSULE in 1 BOTTLE (43598-516-01)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051663

NDC 943598-516
NDC 1043598-516-63
NDC Item43598051663
Packaging28 CAPSULE in 1 BOTTLE (43598-516-63)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048301

NDC 947781-483
NDC 1047781-483-01
NDC Item47781048301
Packaging100 CAPSULE in 1 BOTTLE (47781-483-01)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048328

NDC 947781-483
NDC 1047781-483-28
NDC Item47781048328
Packaging28 CAPSULE in 1 BOTTLE (47781-483-28)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034201

NDC 959651-342
NDC 1059651-342-01
NDC Item59651034201
Packaging100 CAPSULE in 1 BOTTLE (59651-342-01)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034207

NDC 959651-342
NDC 1059651-342-07
NDC Item59651034207
Packaging1 BLISTER PACK in 1 CARTON (59651-342-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034228

NDC 959651-342
NDC 1059651-342-28
NDC Item59651034228
Packaging28 CAPSULE in 1 BOTTLE (59651-342-28)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453202

NDC 960505-4532
NDC 1060505-4532-2
NDC Item60505453202
Packaging28 CAPSULE in 1 BOTTLE (60505-4532-2)
ANDAANDA211022
COLORTEXTWHITE(Opaque),BLUE(Blue green opaque)
ColorC48325;C48333 __
FDA SPL set id707296
Imprint codeAPO;L;2;5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004101

NDC 963304-041
NDC 1063304-041-01
NDC Item63304004101
Packaging100 CAPSULE in 1 BOTTLE (63304-041-01)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004127

NDC 963304-041
NDC 1063304-041-27
NDC Item63304004127
Packaging28 CAPSULE in 1 BOTTLE (63304-041-27)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 69097060473

NDC 969097-604
NDC 1069097-604-73
NDC Item69097060473
Packaging28 CAPSULE in 1 BOTTLE (69097-604-73)
ANDAANDA214618
COLORTEXTBLUE(blue green cap),WHITE(white body)
ColorC48333;C48325 __
FDA SPL set id699517
Imprint codeCipla;2;5mg;604
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 70710103001

NDC 970710-1030
NDC 1070710-1030-1
NDC Item70710103001
Packaging100 CAPSULE in 1 BOTTLE (70710-1030-1)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103007

NDC 970710-1030
NDC 1070710-1030-7
NDC Item70710103007
Packaging28 CAPSULE in 1 BOTTLE (70710-1030-7)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167601

NDC 970771-1676
NDC 1070771-1676-1
NDC Item70771167601
Packaging100 CAPSULE in 1 BOTTLE (70771-1676-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167607

NDC 970771-1676
NDC 1070771-1676-7
NDC Item70771167607
Packaging28 CAPSULE in 1 BOTTLE (70771-1676-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069648

NDC 976282-696
NDC 1076282-696-48
NDC Item76282069648
Packaging28 CAPSULE in 1 BOTTLE (76282-696-48)
ANDAANDA214618
COLORTEXTBLUE(capsule blue green cap and White body)
ColorC48333 __
FDA SPL set id792335
Imprint codeCipla;2;5mg;cap;604;body
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-06-10
Marketing statusactive
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193501

NDC 90378-1935
NDC 100378-1935-01
NDC Item00378193501
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-01)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193528

NDC 90378-1935
NDC 100378-1935-28
NDC Item00378193528
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-28)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00480124128

NDC 90480-1241
NDC 100480-1241-28
NDC Item00480124128
Packaging28 CAPSULE in 1 BOTTLE (0480-1241-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id782674
Imprint codeNAT;2;5mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-08
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 31722025701

NDC 931722-257
NDC 1031722-257-01
NDC Item31722025701
Packaging100 CAPSULE in 1 BOTTLE (31722-257-01)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 31722025728

NDC 931722-257
NDC 1031722-257-28
NDC Item31722025728
Packaging28 CAPSULE in 1 BOTTLE (31722-257-28)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 43598051601

NDC 943598-516
NDC 1043598-516-01
NDC Item43598051601
Packaging100 CAPSULE in 1 BOTTLE (43598-516-01)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051663

NDC 943598-516
NDC 1043598-516-63
NDC Item43598051663
Packaging28 CAPSULE in 1 BOTTLE (43598-516-63)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048301

NDC 947781-483
NDC 1047781-483-01
NDC Item47781048301
Packaging100 CAPSULE in 1 BOTTLE (47781-483-01)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048328

NDC 947781-483
NDC 1047781-483-28
NDC Item47781048328
Packaging28 CAPSULE in 1 BOTTLE (47781-483-28)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034201

NDC 959651-342
NDC 1059651-342-01
NDC Item59651034201
Packaging100 CAPSULE in 1 BOTTLE (59651-342-01)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034207

NDC 959651-342
NDC 1059651-342-07
NDC Item59651034207
Packaging1 BLISTER PACK in 1 CARTON (59651-342-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034228

NDC 959651-342
NDC 1059651-342-28
NDC Item59651034228
Packaging28 CAPSULE in 1 BOTTLE (59651-342-28)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453202

NDC 960505-4532
NDC 1060505-4532-2
NDC Item60505453202
Packaging28 CAPSULE in 1 BOTTLE (60505-4532-2)
ANDAANDA211022
COLORTEXTWHITE(Opaque),BLUE(Blue green opaque)
ColorC48325;C48333 __
FDA SPL set id707296
Imprint codeAPO;L;2;5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004101

NDC 963304-041
NDC 1063304-041-01
NDC Item63304004101
Packaging100 CAPSULE in 1 BOTTLE (63304-041-01)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004127

NDC 963304-041
NDC 1063304-041-27
NDC Item63304004127
Packaging28 CAPSULE in 1 BOTTLE (63304-041-27)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 69097060473

NDC 969097-604
NDC 1069097-604-73
NDC Item69097060473
Packaging28 CAPSULE in 1 BOTTLE (69097-604-73)
ANDAANDA214618
COLORTEXTBLUE(blue green cap),WHITE(white body)
ColorC48333;C48325 __
FDA SPL set id699517
Imprint codeCipla;2;5mg;604
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 70710103001

NDC 970710-1030
NDC 1070710-1030-1
NDC Item70710103001
Packaging100 CAPSULE in 1 BOTTLE (70710-1030-1)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103007

NDC 970710-1030
NDC 1070710-1030-7
NDC Item70710103007
Packaging28 CAPSULE in 1 BOTTLE (70710-1030-7)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167601

NDC 970771-1676
NDC 1070771-1676-1
NDC Item70771167601
Packaging100 CAPSULE in 1 BOTTLE (70771-1676-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167607

NDC 970771-1676
NDC 1070771-1676-7
NDC Item70771167607
Packaging28 CAPSULE in 1 BOTTLE (70771-1676-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069648

NDC 976282-696
NDC 1076282-696-48
NDC Item76282069648
Packaging28 CAPSULE in 1 BOTTLE (76282-696-48)
ANDAANDA214618
COLORTEXTBLUE(capsule blue green cap and White body)
ColorC48333 __
FDA SPL set id792335
Imprint codeCipla;2;5mg;cap;604;body
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-06-10
Marketing statusactive
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193501

NDC 90378-1935
NDC 100378-1935-01
NDC Item00378193501
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-01)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193528

NDC 90378-1935
NDC 100378-1935-28
NDC Item00378193528
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-28)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00480124128

NDC 90480-1241
NDC 100480-1241-28
NDC Item00480124128
Packaging28 CAPSULE in 1 BOTTLE (0480-1241-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id782674
Imprint codeNAT;2;5mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-08
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 31722025701

NDC 931722-257
NDC 1031722-257-01
NDC Item31722025701
Packaging100 CAPSULE in 1 BOTTLE (31722-257-01)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 31722025728

NDC 931722-257
NDC 1031722-257-28
NDC Item31722025728
Packaging28 CAPSULE in 1 BOTTLE (31722-257-28)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 43598051601

NDC 943598-516
NDC 1043598-516-01
NDC Item43598051601
Packaging100 CAPSULE in 1 BOTTLE (43598-516-01)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051663

NDC 943598-516
NDC 1043598-516-63
NDC Item43598051663
Packaging28 CAPSULE in 1 BOTTLE (43598-516-63)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048301

NDC 947781-483
NDC 1047781-483-01
NDC Item47781048301
Packaging100 CAPSULE in 1 BOTTLE (47781-483-01)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048328

NDC 947781-483
NDC 1047781-483-28
NDC Item47781048328
Packaging28 CAPSULE in 1 BOTTLE (47781-483-28)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034201

NDC 959651-342
NDC 1059651-342-01
NDC Item59651034201
Packaging100 CAPSULE in 1 BOTTLE (59651-342-01)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034207

NDC 959651-342
NDC 1059651-342-07
NDC Item59651034207
Packaging1 BLISTER PACK in 1 CARTON (59651-342-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034228

NDC 959651-342
NDC 1059651-342-28
NDC Item59651034228
Packaging28 CAPSULE in 1 BOTTLE (59651-342-28)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453202

NDC 960505-4532
NDC 1060505-4532-2
NDC Item60505453202
Packaging28 CAPSULE in 1 BOTTLE (60505-4532-2)
ANDAANDA211022
COLORTEXTWHITE(Opaque),BLUE(Blue green opaque)
ColorC48325;C48333 __
FDA SPL set id707296
Imprint codeAPO;L;2;5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004101

NDC 963304-041
NDC 1063304-041-01
NDC Item63304004101
Packaging100 CAPSULE in 1 BOTTLE (63304-041-01)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63304-041

NDC Item 63304004127

NDC 963304-041
NDC 1063304-041-27
NDC Item63304004127
Packaging28 CAPSULE in 1 BOTTLE (63304-041-27)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 69097060473

NDC 969097-604
NDC 1069097-604-73
NDC Item69097060473
Packaging28 CAPSULE in 1 BOTTLE (69097-604-73)
ANDAANDA214618
COLORTEXTBLUE(blue green cap),WHITE(white body)
ColorC48333;C48325 __
FDA SPL set id699517
Imprint codeCipla;2;5mg;604
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 70710103001

NDC 970710-1030
NDC 1070710-1030-1
NDC Item70710103001
Packaging100 CAPSULE in 1 BOTTLE (70710-1030-1)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103007

NDC 970710-1030
NDC 1070710-1030-7
NDC Item70710103007
Packaging28 CAPSULE in 1 BOTTLE (70710-1030-7)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167601

NDC 970771-1676
NDC 1070771-1676-1
NDC Item70771167601
Packaging100 CAPSULE in 1 BOTTLE (70771-1676-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70771167607

NDC 970771-1676
NDC 1070771-1676-7
NDC Item70771167607
Packaging28 CAPSULE in 1 BOTTLE (70771-1676-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 76282069648

NDC 976282-696
NDC 1076282-696-48
NDC Item76282069648
Packaging28 CAPSULE in 1 BOTTLE (76282-696-48)
ANDAANDA214618
COLORTEXTBLUE(capsule blue green cap and White body)
ColorC48333 __
FDA SPL set id792335
Imprint codeCipla;2;5mg;cap;604;body
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-06-10
Marketing statusactive
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193501

NDC 90378-1935
NDC 100378-1935-01
NDC Item00378193501
Packaging100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-01)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00378193528

NDC 90378-1935
NDC 100378-1935-28
NDC Item00378193528
Packaging28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-28)
ANDAANDA213912
COLORTEXTGREEN(green opaque),WHITE(white opaque)
ColorC48329;C48325 __
FDA SPL set id745620
Imprint codeMYLAN;LL;2;5
LabelerMylan Pharmaceuticals Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 00480124128

NDC 90480-1241
NDC 100480-1241-28
NDC Item00480124128
Packaging28 CAPSULE in 1 BOTTLE (0480-1241-28)
ANDAANDA201452
COLORTEXTwhite
ColorC48325 __
FDA SPL set id782674
Imprint codeNAT;2;5mg
LabelerTeva Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-08
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 31722025701

NDC 931722-257
NDC 1031722-257-01
NDC Item31722025701
Packaging100 CAPSULE in 1 BOTTLE (31722-257-01)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
Related queriesProperties for NDC 9 31722-257

NDC Item 31722025728

NDC 931722-257
NDC 1031722-257-28
NDC Item31722025728
Packaging28 CAPSULE in 1 BOTTLE (31722-257-28)
ANDAANDA212414
COLORTEXTpink,white
ColorC48328;C48325 __
FDA SPL set id718892
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm
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NDC Item 43598051601

NDC 943598-516
NDC 1043598-516-01
NDC Item43598051601
Packaging100 CAPSULE in 1 BOTTLE (43598-516-01)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 43598051663

NDC 943598-516
NDC 1043598-516-63
NDC Item43598051663
Packaging28 CAPSULE in 1 BOTTLE (43598-516-63)
ANDAANDA209348
COLORTEXTGREEN(pale green opaque colored cap),GREEN(pale green opaque colored body)
ColorC48329;C48329 __
FDA SPL set id727151
Imprint codeRDY;2;5;mg
LabelerDr. Reddy's Laboratories Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2022-09-07
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048301

NDC 947781-483
NDC 1047781-483-01
NDC Item47781048301
Packaging100 CAPSULE in 1 BOTTLE (47781-483-01)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 47781048328

NDC 947781-483
NDC 1047781-483-28
NDC Item47781048328
Packaging28 CAPSULE in 1 BOTTLE (47781-483-28)
ANDAANDA210480
COLORTEXTBLUE(DARK BLUE),ORANGE(LIGHT ORANGE)
ColorC48333;C48331 __
FDA SPL set id789803
Imprint codeLP;637
LabelerAlvogen, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034201

NDC 959651-342
NDC 1059651-342-01
NDC Item59651034201
Packaging100 CAPSULE in 1 BOTTLE (59651-342-01)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 59651-342

NDC Item 59651034207

NDC 959651-342
NDC 1059651-342-07
NDC Item59651034207
Packaging1 BLISTER PACK in 1 CARTON (59651-342-07) / 7 CAPSULE in 1 BLISTER PACK
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 59651034228

NDC 959651-342
NDC 1059651-342-28
NDC Item59651034228
Packaging28 CAPSULE in 1 BOTTLE (59651-342-28)
ANDAANDA213885
COLORTEXTGREEN(Green Opaque Cap, Green Opaque Body)
ColorC48329 __
FDA SPL set id717399
Imprint codeL2;5
LabelerAurobindo Pharma Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-06
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 60505453202

NDC 960505-4532
NDC 1060505-4532-2
NDC Item60505453202
Packaging28 CAPSULE in 1 BOTTLE (60505-4532-2)
ANDAANDA211022
COLORTEXTWHITE(Opaque),BLUE(Blue green opaque)
ColorC48325;C48333 __
FDA SPL set id707296
Imprint codeAPO;L;2;5
LabelerApotex Corp.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004101

NDC 963304-041
NDC 1063304-041-01
NDC Item63304004101
Packaging100 CAPSULE in 1 BOTTLE (63304-041-01)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
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NDC Item 63304004127

NDC 963304-041
NDC 1063304-041-27
NDC Item63304004127
Packaging28 CAPSULE in 1 BOTTLE (63304-041-27)
ANDAANDA211846
COLORTEXTwhite,white
ColorC48325;C48325 __
FDA SPL set id701728
Imprint codeRL;;78
LabelerSun Pharmaceutical Industries, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-12
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 63304-041

NDC Item 69097060473

NDC 969097-604
NDC 1069097-604-73
NDC Item69097060473
Packaging28 CAPSULE in 1 BOTTLE (69097-604-73)
ANDAANDA214618
COLORTEXTBLUE(blue green cap),WHITE(white body)
ColorC48333;C48325 __
FDA SPL set id699517
Imprint codeCipla;2;5mg;604
LabelerCipla USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-09
Marketing statusACTIVE
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 69097-604

NDC Item 70710103001

NDC 970710-1030
NDC 1070710-1030-1
NDC Item70710103001
Packaging100 CAPSULE in 1 BOTTLE (70710-1030-1)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
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NDC Item 70710103007

NDC 970710-1030
NDC 1070710-1030-7
NDC Item70710103007
Packaging28 CAPSULE in 1 BOTTLE (70710-1030-7)
ANDAANDA210154
COLORTEXTWHITE(opaque white cap),BLUE(blue opaque body)
ColorC48325;C48333 __
FDA SPL set id770365
Imprint code1030
LabelerZydus Pharmaceuticals USA Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
Related queriesProperties for NDC 9 70710-1030

NDC Item 70771167601

NDC 970771-1676
NDC 1070771-1676-1
NDC Item70771167601
Packaging100 CAPSULE in 1 BOTTLE (70771-1676-1)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
Related queriesProperties for NDC 9 70771-1676

NDC Item 70771167607

NDC 970771-1676
NDC 1070771-1676-7
NDC Item70771167607
Packaging28 CAPSULE in 1 BOTTLE (70771-1676-7)
ANDAANDA210154
COLORTEXTWHITE(white opaque cap with blue opaque body)
ColorC48325 __
FDA SPL set id731991
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm
Related queriesProperties for NDC 9 70771-1676

NDC Item 76282069648

NDC 976282-696
NDC 1076282-696-48
NDC Item76282069648
Packaging28 CAPSULE in 1 BOTTLE (76282-696-48)
ANDAANDA214618
COLORTEXTBLUE(capsule blue green cap and White body)
ColorC48333 __
FDA SPL set id792335
Imprint codeCipla;2;5mg;cap;604;body
LabelerEXELAN PHARMACEUTICALS INC.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2024-06-10
Marketing statusactive
Score1
ShapeC48336
Size14 mm
Related queriesProperties for NDC 9 76282-696