NDC Code(s) : 60687-157-11, 60687-157-21, 60687-168-11, 60687-168-01, 60687-179-11, 60687-179-01, 60687-191-11, 60687-191-21, 60687-202-11, 60687-202-21, 60687-213-11, 60687-213-21
Packager : American Health Packaging

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AripiprazoleAripiprazole TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-157(NDC:31722-819)
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
STARCH, CORN(UNII: O8232NY3SJ)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
Product Characteristics
Color green Score no score
Shape RECTANGLE Size 8 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60687-157-2130 in 1 BOX, UNIT-DOSE 06/05/2015
1NDC:60687-157-111 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205064 06/05/2015
AripiprazoleAripiprazole TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-168(NDC:31722-820)
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
STARCH, CORN(UNII: O8232NY3SJ)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
Product Characteristics
Color blue Score no score
Shape RECTANGLE Size 8 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60687-168-01100 in 1 BOX, UNIT-DOSE 06/09/2015
1NDC:60687-168-111 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205064 06/09/2015
AripiprazoleAripiprazole TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-179(NDC:31722-827)
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
STARCH, CORN(UNII: O8232NY3SJ)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
Product Characteristics
Color pink Score no score
Shape RECTANGLE Size 8 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60687-179-01100 in 1 BOX, UNIT-DOSE 06/09/2015
1NDC:60687-179-111 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205064 06/09/2015
AripiprazoleAripiprazole TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-191(NDC:31722-828)
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
STARCH, CORN(UNII: O8232NY3SJ)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
Product Characteristics
Color yellow Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60687-191-2130 in 1 BOX, UNIT-DOSE 06/05/2015
1NDC:60687-191-111 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205064 06/05/2015
AripiprazoleAripiprazole TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-202(NDC:31722-829)
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
STARCH, CORN(UNII: O8232NY3SJ)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
Product Characteristics
Color white (off-white) Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60687-202-2130 in 1 BOX, UNIT-DOSE 06/05/2015
1NDC:60687-202-111 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205064 06/05/2015
AripiprazoleAripiprazole TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-213(NDC:31722-830)
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
STARCH, CORN(UNII: O8232NY3SJ)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
Product Characteristics
Color pink Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60687-213-2130 in 1 BOX, UNIT-DOSE 06/05/2015
1NDC:60687-213-111 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205064 06/05/2015

LABELER - American Health Packaging(929561009)

Establishment
Name Address ID/FEI Business Operations
American Health Packaging 929561009 repack(60687-157, 60687-168, 60687-179, 60687-191, 60687-202, 60687-213)

PRINCIPAL DISPLAY PANEL

2 mg Aripiprazole Tablets Carton

NDC 60687- 157-21

Aripiprazole
Tablets, USP

2 mg

30 Tablets (3 x 10)                Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Tablet Contains:
Aripiprazole USP……...............……………..……………......…2 mg

Usual Dosage: See package insert for full prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 31722-819, Camber Pharmaceuticals, Inc.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

715721
0415721/1018OS

PRINCIPAL DISPLAY PANEL

2 mg Aripiprazole Tablet Blister

Aripiprazole
Tablet, USP

2 mg

PRINCIPAL DISPLAY PANEL

5 mg Aripiprazole Tablets Carton

NDC 60687- 168-01

Aripiprazole
Tablets, USP

5 mg

100 Tablets (10 x 10)                Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Tablet Contains:
Aripiprazole USP…………........................…....…….…5 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled
Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or
broken.

The drug product contained in this package is from
NDC # 31722-820, Camber Pharmaceuticals, Inc.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

716801
0416801/1018OS

PRINCIPAL DISPLAY PANEL

5 mg Aripiprazole Tablet Blister

Aripiprazole
Tablet, USP

5 mg

PRINCIPAL DISPLAY PANEL

10 mg Aripiprazole Tablets Carton

NDC 60687- 179-01

Aripiprazole
Tablets, USP

10 mg

100 Tablets (10 x 10)                Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Tablet Contains:
Aripiprazole USP…….......................……………..………10 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled
Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or
broken.

The drug product contained in this package is from
NDC # 31722-827, Camber Pharmaceuticals, Inc.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

717901
0417901/1018OS

PRINCIPAL DISPLAY PANEL

10 mg Aripiprazole Tablet Blister

Aripiprazole
Tablet, USP

10 mg

PRINCIPAL DISPLAY PANEL

15 mg Aripiprazole Tablets Carton

NDC 60687- 191-21

Aripiprazole
Tablets, USP

15 mg

30 Tablets (3 x 10)                Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Tablet Contains:
Aripiprazole USP…...........………………..………………........15 mg

Usual Dosage: See package insert for full prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 31722-828, Camber Pharmaceuticals, Inc.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

719121
0419121/1018OS

PRINCIPAL DISPLAY PANEL

15 mg Aripiprazole Tablet Blister

Aripiprazole
Tablet, USP

15 mg

PRINCIPAL DISPLAY PANEL

20 mg Aripiprazole Tablets Carton

NDC 60687- 202-21

Aripiprazole
Tablets, USP

20 mg

30 Tablets (3 x 10)                Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Tablet Contains:
Aripiprazole USP…………………...............………………20 mg

Usual Dosage: See package insert for full prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 31722-829, Camber Pharmaceuticals, Inc.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

720221
0420221/1018OS

PRINCIPAL DISPLAY PANEL

20 mg Aripiprazole Tablet Blister

Aripiprazole
Tablet, USP

20 mg

PRINCIPAL DISPLAY PANEL

30 mg Aripiprazole Tablets Carton

NDC 60687- 213-21

Aripiprazole
Tablets, USP

30 mg

30 Tablets (3 x 10)                Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Tablet Contains:
Aripiprazole USP……...............……………..……………....…30 mg

Usual Dosage: See package insert for full prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 31722-830, Camber Pharmaceuticals, Inc.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

721321
0421321/1018OS

PRINCIPAL DISPLAY PANEL

30 mg Aripiprazole Tablet Blister

Aripiprazole
Tablet, USP

30 mg