NDC Code(s) : 67877-431-03, 67877-431-01, 67877-431-05, 67877-431-33, 67877-431-38, 67877-431-32, 67877-432-03, 67877-432-01, 67877-432-05, 67877-432-33, 67877-432-38, 67877-432-32, 67877-433-03, 67877-433-01, 67877-433-05, 67877-433-33, 67877-433-38, 67877-433-32, 67877-434-03, 67877-434-01, 67877-434-05, 67877-434-33, 67877-434-38, 67877-435-03, 67877-435-01, 67877-435-05, 67877-435-33, 67877-435-38, 67877-430-03, 67877-430-01, 67877-430-05, 67877-430-33, 67877-430-38, 67877-430-32
Packager : Ascend Laboratories, LLC

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:67877-431
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)
STARCH, CORN(UNII: O8232NY3SJ)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color BLUE Score no score
Shape RECTANGLE (modified rectangle) Size 8 mm
Flavor Imprint Code ARI;5
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-431-0330 in 1 BOTTLE Type 0: Not a Combination Product27/02/2019
2NDC:67877-431-01100 in 1 BOTTLE Type 0: Not a Combination Product27/02/2019
3NDC:67877-431-05500 in 1 BOTTLE Type 0: Not a Combination Product27/02/2019
4NDC:67877-431-3810 in 1 CARTON 27/02/2019
4NDC:67877-431-3310 in 1 BLISTER PACK Type 0: Not a Combination Product27/02/2019
5NDC:67877-431-321 in 1 CARTON 27/02/2019
57 in 1 BLISTER PACK Type 0: Not a Combination Product27/02/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207105 02/27/2019
Aripiprazole Aripiprazole TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:67877-432
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)
STARCH, CORN(UNII: O8232NY3SJ)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color PINK Score no score
Shape RECTANGLE (modified rectangle) Size 8 mm
Flavor Imprint Code ARI;10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-432-0330 in 1 BOTTLE Type 0: Not a Combination Product27/02/2019
2NDC:67877-432-01100 in 1 BOTTLE Type 0: Not a Combination Product27/02/2019
3NDC:67877-432-05500 in 1 BOTTLE Type 0: Not a Combination Product27/02/2019
4NDC:67877-432-3810 in 1 CARTON 27/02/2019
4NDC:67877-432-3310 in 1 BLISTER PACK Type 0: Not a Combination Product27/02/2019
5NDC:67877-432-321 in 1 CARTON 27/02/2019
57 in 1 BLISTER PACK Type 0: Not a Combination Product27/02/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207105 02/27/2019
Aripiprazole Aripiprazole TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:67877-433
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)
STARCH, CORN(UNII: O8232NY3SJ)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code ARI;15
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-433-0330 in 1 BOTTLE Type 0: Not a Combination Product27/02/2019
2NDC:67877-433-01100 in 1 BOTTLE Type 0: Not a Combination Product27/02/2019
3NDC:67877-433-05500 in 1 BOTTLE Type 0: Not a Combination Product27/02/2019
4NDC:67877-433-3810 in 1 CARTON 27/02/2019
4NDC:67877-433-3310 in 1 BLISTER PACK Type 0: Not a Combination Product27/02/2019
5NDC:67877-433-321 in 1 CARTON 27/02/2019
57 in 1 BLISTER PACK Type 0: Not a Combination Product27/02/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207105 02/27/2019
Aripiprazole Aripiprazole TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:67877-434
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)
STARCH, CORN(UNII: O8232NY3SJ)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (off white) Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code ARI;20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-434-0330 in 1 BOTTLE Type 0: Not a Combination Product27/02/2019
2NDC:67877-434-01100 in 1 BOTTLE Type 0: Not a Combination Product27/02/2019
3NDC:67877-434-05500 in 1 BOTTLE Type 0: Not a Combination Product27/02/2019
4NDC:67877-434-3810 in 1 CARTON 27/02/2019
4NDC:67877-434-3310 in 1 BLISTER PACK Type 0: Not a Combination Product27/02/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207105 02/27/2019
Aripiprazole Aripiprazole TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:67877-435
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)
STARCH, CORN(UNII: O8232NY3SJ)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color PINK Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code ARI;30
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-435-0330 in 1 BOTTLE Type 0: Not a Combination Product27/02/2019
2NDC:67877-435-01100 in 1 BOTTLE Type 0: Not a Combination Product27/02/2019
3NDC:67877-435-05500 in 1 BOTTLE Type 0: Not a Combination Product27/02/2019
4NDC:67877-435-3810 in 1 CARTON 27/02/2019
4NDC:67877-435-3310 in 1 BLISTER PACK Type 0: Not a Combination Product27/02/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207105 02/27/2019
Aripiprazole Aripiprazole TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:67877-430
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)
STARCH, CORN(UNII: O8232NY3SJ)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color GREEN Score no score
Shape RECTANGLE (modified rectangle) Size 8 mm
Flavor Imprint Code ARI;2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-430-0330 in 1 BOTTLE Type 0: Not a Combination Product27/02/2019
2NDC:67877-430-01100 in 1 BOTTLE Type 0: Not a Combination Product27/02/2019
3NDC:67877-430-05500 in 1 BOTTLE Type 0: Not a Combination Product27/02/2019
4NDC:67877-430-3810 in 1 CARTON 27/02/2019
4NDC:67877-430-3310 in 1 BLISTER PACK Type 0: Not a Combination Product27/02/2019
5NDC:67877-430-321 in 1 CARTON 27/02/2019
57 in 1 BLISTER PACK Type 0: Not a Combination Product27/02/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207105 02/27/2019

LABELER - Ascend Laboratories, LLC(141250469)

Establishment
Name Address ID/FEI Business Operations
Alkem Laboratories Limited 915628612 MANUFACTURE(67877-430, 67877-431, 67877-432, 67877-433, 67877-434, 67877-435)

PRINCIPAL DISPLAY PANEL

NDC 67877-430-03
Aripiprazole Tablets, USP 2 mg
Rx Only
30 Tablets
aripiprazole-fig1a
NDC 67877-431-01
A ripiprazole Tablets, USP 5 mg
Rx Only
100 Tablets
aripiprazole-fig1a
NDC 67877-432-05
A ripiprazole Tablets, USP 10 mg
Rx Only
500 Tablets
aripiprazole-fig1a
NDC 67877-433-03
A ripiprazole Tablets, USP 15 mg
Rx Only
30 Tablets
aripiprazole-fig1a
NDC 67877-434-01
A ripiprazole Tablets, USP 20 mg
Rx Only
100 Tablets
aripiprazole-fig1a
NDC 67877-435-05
A ripiprazole Tablets, USP 30 mg
Rx Only
500 Tablets
 aripiprazole-fig1a