NDC Code(s) : 62332-097-30, 62332-097-60, 62332-097-45, 62332-097-71, 62332-097-91, 62332-097-31, 62332-097-10, 62332-098-30, 62332-098-60, 62332-098-31, 62332-098-45, 62332-098-91, 62332-098-10, 62332-098-71, 62332-099-30, 62332-099-31, 62332-099-71, 62332-099-91, 62332-099-10, 62332-100-30, 62332-100-31, 62332-100-71, 62332-100-91, 62332-100-10, 62332-101-30, 62332-101-31, 62332-101-71, 62332-101-91, 62332-101-10, 62332-102-30, 62332-102-31, 62332-102-71, 62332-102-91, 62332-102-10
Packager : Alembic Pharmaceuticals Inc.

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Aripiprazole Aripiprazole TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:62332-097
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE(UNII: 82VFR53I78)
(ARIPIPRAZOLE - UNII:82VFR53I78) 		ARIPIPRAZOLE2 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
STARCH, CORN(UNII: O8232NY3SJ)
CROSPOVIDONE(UNII: 68401960MK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color WHITE (Off white to cream) Score no score
Shape RECTANGLE (modified rectangular) Size 8 mm
Flavor Imprint Code 251
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62332-097-3030 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
2NDC:62332-097-6060 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
3NDC:62332-097-45180 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
4NDC:62332-097-71500 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
5NDC:62332-097-911000 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
6NDC:62332-097-31100 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
7NDC:62332-097-10100 in 1 CARTON Type 0: Not a Combination Product07/07/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202101 07/07/2016
Aripiprazole Aripiprazole TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:62332-098
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE(UNII: 82VFR53I78)
(ARIPIPRAZOLE - UNII:82VFR53I78) 		ARIPIPRAZOLE5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
STARCH, CORN(UNII: O8232NY3SJ)
CROSPOVIDONE(UNII: 68401960MK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color PINK (off-white to light pink) Score no score
Shape RECTANGLE (modified rectangular) Size 8 mm
Flavor Imprint Code 250
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62332-098-3030 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
2NDC:62332-098-6060 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
3NDC:62332-098-31100 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
4NDC:62332-098-45180 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
5NDC:62332-098-911000 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
6NDC:62332-098-10100 in 1 CARTON Type 0: Not a Combination Product07/07/2016
7NDC:62332-098-71500 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202101 07/07/2016
Aripiprazole Aripiprazole TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:62332-099
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE(UNII: 82VFR53I78)
(ARIPIPRAZOLE - UNII:82VFR53I78) 		ARIPIPRAZOLE10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
STARCH, CORN(UNII: O8232NY3SJ)
CROSPOVIDONE(UNII: 68401960MK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (White to off-White) Score no score
Shape RECTANGLE (modified rectangular) Size 8 mm
Flavor Imprint Code 252
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62332-099-3030 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
2NDC:62332-099-31100 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
3NDC:62332-099-71500 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
4NDC:62332-099-911000 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
5NDC:62332-099-10100 in 1 CARTON Type 0: Not a Combination Product07/07/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202101 07/07/2016
Aripiprazole Aripiprazole TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:62332-100
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE(UNII: 82VFR53I78)
(ARIPIPRAZOLE - UNII:82VFR53I78) 		ARIPIPRAZOLE15 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
STARCH, CORN(UNII: O8232NY3SJ)
CROSPOVIDONE(UNII: 68401960MK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (White to off-White) Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code 253
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62332-100-3030 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
2NDC:62332-100-31100 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
3NDC:62332-100-71500 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
4NDC:62332-100-911000 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
5NDC:62332-100-10100 in 1 CARTON Type 0: Not a Combination Product07/07/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202101 07/07/2016
Aripiprazole Aripiprazole TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:62332-101
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE(UNII: 82VFR53I78)
(ARIPIPRAZOLE - UNII:82VFR53I78) 		ARIPIPRAZOLE20 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
STARCH, CORN(UNII: O8232NY3SJ)
CROSPOVIDONE(UNII: 68401960MK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (White to off-White) Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code L254
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62332-101-3030 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
2NDC:62332-101-31100 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
3NDC:62332-101-71500 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
4NDC:62332-101-911000 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
5NDC:62332-101-10100 in 1 CARTON Type 0: Not a Combination Product07/07/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202101 07/07/2016
Aripiprazole Aripiprazole TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:62332-102
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE(UNII: 82VFR53I78)
(ARIPIPRAZOLE - UNII:82VFR53I78) 		ARIPIPRAZOLE30 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
STARCH, CORN(UNII: O8232NY3SJ)
CROSPOVIDONE(UNII: 68401960MK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (White to off-White) Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code L255
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62332-102-3030 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
2NDC:62332-102-31100 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
3NDC:62332-102-71500 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
4NDC:62332-102-911000 in 1 BOTTLE Type 0: Not a Combination Product07/07/2016
5NDC:62332-102-10100 in 1 CARTON Type 0: Not a Combination Product07/07/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202101 07/07/2016

LABELER - Alembic Pharmaceuticals Inc.(079288842)

Establishment
Name Address ID/FEI Business Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE(62332-097, 62332-098, 62332-099, 62332-100, 62332-101, 62332-102)

PRINCIPAL DISPLAY PANEL

NDC 62332-097-30
Aripiprazole
Tablets, USP
2 mg
PHARMACIST: DISPENSE WITH
MEDICATION GUIDE
Rx only
30 Tablets
Alembic

30tablets

 



PRINCIPAL DISPLAY PANEL

NDC 62332-098-30
Aripiprazole
Tablets, USP
5 mg
PHARMACIST: DISPENSE WITH
MEDICATION GUIDE
Rx only
30 Tablets
Alembic

30tablets


PRINCIPAL DISPLAY PANEL

NDC 62332-099-30
Aripiprazole
Tablets, USP
10 mg
PHARMACIST: DISPENSE WITH
MEDICATION GUIDE
Rx only
30 Tablets
Alembic

30tablets


PRINCIPAL DISPLAY PANEL

NDC 62332-100-30
Aripiprazole
Tablets, USP
15 mg
PHARMACIST: DISPENSE WITH
MEDICATION GUIDE
Rx only
30 Tablets
Alembic

30tablets


PRINCIPAL DISPLAY PANEL

NDC 62332-101-30
Aripiprazole
Tablets, USP
20 mg
PHARMACIST: DISPENSE WITH
MEDICATION GUIDE
Rx only
30 Tablets
Alembic

30tablets

PRINCIPAL DISPLAY PANEL

NDC 62332-102-30
Aripiprazole
Tablets, USP
30 mg
PHARMACIST: DISPENSE WITH
MEDICATION GUIDE
Rx only
30 Tablets
Alembic

30tablets