NDC Code 65162-902-03 - Aripiprazole

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARIPIPRAZOLE(UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)	ARIPIPRAZOLE	2 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65162-896-03	30 in 1 BOTTLE Type 0: Not a Combination Product	20/06/2016
2	NDC:65162-896-09	90 in 1 BOTTLE Type 0: Not a Combination Product	20/06/2016
3	NDC:65162-896-50	500 in 1 BOTTLE Type 0: Not a Combination Product	20/06/2016
4	NDC:65162-896-11	1000 in 1 BOTTLE Type 0: Not a Combination Product	20/06/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARIPIPRAZOLE(UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)	ARIPIPRAZOLE	5 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65162-897-03	30 in 1 BOTTLE Type 0: Not a Combination Product	20/06/2016
2	NDC:65162-897-09	90 in 1 BOTTLE Type 0: Not a Combination Product	20/06/2016
3	NDC:65162-897-50	500 in 1 BOTTLE Type 0: Not a Combination Product	20/06/2016
4	NDC:65162-897-11	1000 in 1 BOTTLE Type 0: Not a Combination Product	20/06/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARIPIPRAZOLE(UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)	ARIPIPRAZOLE	10 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65162-898-03	30 in 1 BOTTLE Type 0: Not a Combination Product	20/06/2016
2	NDC:65162-898-09	90 in 1 BOTTLE Type 0: Not a Combination Product	20/06/2016
3	NDC:65162-898-50	500 in 1 BOTTLE Type 0: Not a Combination Product	20/06/2016
4	NDC:65162-898-11	1000 in 1 BOTTLE Type 0: Not a Combination Product	20/06/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARIPIPRAZOLE(UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)	ARIPIPRAZOLE	15 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65162-899-03	30 in 1 BOTTLE Type 0: Not a Combination Product	20/06/2016
2	NDC:65162-899-09	90 in 1 BOTTLE Type 0: Not a Combination Product	20/06/2016
3	NDC:65162-899-50	500 in 1 BOTTLE Type 0: Not a Combination Product	20/06/2016
4	NDC:65162-899-11	1000 in 1 BOTTLE Type 0: Not a Combination Product	20/06/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARIPIPRAZOLE(UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)	ARIPIPRAZOLE	20 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65162-901-03	30 in 1 BOTTLE Type 0: Not a Combination Product	20/06/2016
2	NDC:65162-901-09	90 in 1 BOTTLE Type 0: Not a Combination Product	20/06/2016
3	NDC:65162-901-50	500 in 1 BOTTLE Type 0: Not a Combination Product	20/06/2016
4	NDC:65162-901-11	1000 in 1 BOTTLE Type 0: Not a Combination Product	20/06/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARIPIPRAZOLE(UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)	ARIPIPRAZOLE	30 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65162-902-03	30 in 1 BOTTLE Type 0: Not a Combination Product	20/06/2016
2	NDC:65162-902-09	90 in 1 BOTTLE Type 0: Not a Combination Product	20/06/2016
3	NDC:65162-902-50	500 in 1 BOTTLE Type 0: Not a Combination Product	20/06/2016
4	NDC:65162-902-11	1000 in 1 BOTTLE Type 0: Not a Combination Product	20/06/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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)

NDC 65162-902-03
API & Excipient Details

Aripiprazole marketed by Amneal Pharmaceuticals LLC under NDC Code 65162-902-03

INGREDIENTS AND APPEARANCE

NDC 65162-902-03 API & Excipient Details

Aripiprazole marketed by Amneal Pharmaceuticals LLC under NDC Code 65162-902-03

INGREDIENTS AND APPEARANCE

NDC 65162-902-03
API & Excipient Details