NDC Code(s) : 65162-896-03, 65162-896-09, 65162-896-50, 65162-896-11, 65162-897-03, 65162-897-09, 65162-897-50, 65162-897-11, 65162-898-03, 65162-898-09, 65162-898-50, 65162-898-11, 65162-899-03, 65162-899-09, 65162-899-50, 65162-899-11, 65162-901-03, 65162-901-09, 65162-901-50, 65162-901-11, 65162-902-03, 65162-902-09, 65162-902-50, 65162-902-11
Packager : Amneal Pharmaceuticals LLC

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:65162-896
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
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
TARTARIC ACID(UNII: W4888I119H)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color green (light green mosaic appearance) Score no score
Shape RECTANGLE (modified) Size 8 mm
Flavor Imprint Code AN896;2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65162-896-0330 in 1 BOTTLE Type 0: Not a Combination Product20/06/2016
2NDC:65162-896-0990 in 1 BOTTLE Type 0: Not a Combination Product20/06/2016
3NDC:65162-896-50500 in 1 BOTTLE Type 0: Not a Combination Product20/06/2016
4NDC:65162-896-111000 in 1 BOTTLE Type 0: Not a Combination Product20/06/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204838 06/20/2016
AripiprazoleAripiprazole TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-897
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
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
TARTARIC ACID(UNII: W4888I119H)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color blue (light blue mosaic appearance) Score no score
Shape RECTANGLE (modified) Size 8 mm
Flavor Imprint Code AN897;5
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65162-897-0330 in 1 BOTTLE Type 0: Not a Combination Product20/06/2016
2NDC:65162-897-0990 in 1 BOTTLE Type 0: Not a Combination Product20/06/2016
3NDC:65162-897-50500 in 1 BOTTLE Type 0: Not a Combination Product20/06/2016
4NDC:65162-897-111000 in 1 BOTTLE Type 0: Not a Combination Product20/06/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204838 06/20/2016
AripiprazoleAripiprazole TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-898
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
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
TARTARIC ACID(UNII: W4888I119H)
FD&C RED NO. 40(UNII: WZB9127XOA)
Product Characteristics
Color pink (light pink mosaic appearance) Score no score
Shape RECTANGLE (modified) Size 8 mm
Flavor Imprint Code AN898;10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65162-898-0330 in 1 BOTTLE Type 0: Not a Combination Product20/06/2016
2NDC:65162-898-0990 in 1 BOTTLE Type 0: Not a Combination Product20/06/2016
3NDC:65162-898-50500 in 1 BOTTLE Type 0: Not a Combination Product20/06/2016
4NDC:65162-898-111000 in 1 BOTTLE Type 0: Not a Combination Product20/06/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204838 06/20/2016
AripiprazoleAripiprazole TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-899
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
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
TARTARIC ACID(UNII: W4888I119H)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color yellow (light yellow mosaic appearance) Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code AN899;15
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65162-899-0330 in 1 BOTTLE Type 0: Not a Combination Product20/06/2016
2NDC:65162-899-0990 in 1 BOTTLE Type 0: Not a Combination Product20/06/2016
3NDC:65162-899-50500 in 1 BOTTLE Type 0: Not a Combination Product20/06/2016
4NDC:65162-899-111000 in 1 BOTTLE Type 0: Not a Combination Product20/06/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204838 06/20/2016
AripiprazoleAripiprazole TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-901
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
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
TARTARIC ACID(UNII: W4888I119H)
Product Characteristics
Color white (off white) Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code AN901;20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65162-901-0330 in 1 BOTTLE Type 0: Not a Combination Product20/06/2016
2NDC:65162-901-0990 in 1 BOTTLE Type 0: Not a Combination Product20/06/2016
3NDC:65162-901-50500 in 1 BOTTLE Type 0: Not a Combination Product20/06/2016
4NDC:65162-901-111000 in 1 BOTTLE Type 0: Not a Combination Product20/06/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204838 06/20/2016
AripiprazoleAripiprazole TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-902
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
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
TARTARIC ACID(UNII: W4888I119H)
FD&C RED NO. 40(UNII: WZB9127XOA)
Product Characteristics
Color pink (light pink mosaic appearance) Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code AN902;30
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65162-902-0330 in 1 BOTTLE Type 0: Not a Combination Product20/06/2016
2NDC:65162-902-0990 in 1 BOTTLE Type 0: Not a Combination Product20/06/2016
3NDC:65162-902-50500 in 1 BOTTLE Type 0: Not a Combination Product20/06/2016
4NDC:65162-902-111000 in 1 BOTTLE Type 0: Not a Combination Product20/06/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204838 06/20/2016

LABELER - Amneal Pharmaceuticals LLC(123797875)

Establishment
Name Address ID/FEI Business Operations
Amneal Pharmaceuticals Private Limited 915076126 analysis(65162-896, 65162-897, 65162-898, 65162-899, 65162-901, 65162-902), label(65162-896, 65162-897, 65162-898, 65162-899, 65162-901, 65162-902), manufacture(65162-896, 65162-897, 65162-898, 65162-899, 65162-901, 65162-902), pack(65162-896, 65162-897, 65162-898, 65162-899, 65162-901, 65162-902)