Aripiprazole

Basic Information

Product Name

Aripiprazole

FDA Product Code

72865-185

Regulatory Information

NDC Product Code

72865-185

Application Number

ANDA205064

Marketing Category

C73584

Effective Date

June 16, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval: 2002

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

ARIPIPRAZOLE

Quantity: 30 mg in 1 1

Code: 82VFR53I78

Class Code: ACTIB

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIED

Code: 9XZ8H6N6OH

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

Active Moieties

Code: 82VFR53I78

Aripiprazole

Basic Information

Regulatory Information

Company Information

Active Ingredients

FD&C BLUE NO. 2

STARCH, CORN

HYDROXYPROPYL CELLULOSE, UNSPECIFIED

FERRIC OXIDE YELLOW

FERRIC OXIDE RED

MICROCRYSTALLINE CELLULOSE

LACTOSE MONOHYDRATE

MAGNESIUM STEARATE

Active Moieties

ARIPIPRAZOLE