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NDC properties for NDC 9 0378-1935

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

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

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

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 id802288
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm

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 id802288
Imprint codeH;L1
LabelerCamber Pharmaceuticals, Inc.
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-05-11
Marketing statusACTIVE
Score1
ShapeC48336
Size15 mm

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

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

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

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

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

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

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

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 id794910
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

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

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

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

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

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

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 id800438
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm

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 id800438
Imprint code1030
LabelerZydus Lifesciences Limited
Label typeHUMAN PRESCRIPTION DRUG
Marketing categoryANDA
Marketing effective time low2023-03-07
Marketing statusACTIVE
Score1
Shapetextcapsule
ShapeC48336
Size11 mm

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