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ABILIFY

These highlights do not include all the information needed to use ABILIFY safely and effectively. See full prescribing information for ABILIFY.ABILIFY (aripiprazole) TabletsABILIFY DISCMELT (aripiprazole) Orally Disintegrating TabletsABILIFY (aripiprazole) Oral SolutionABILIFY (aripiprazole) Injection FOR INTRAMUSCULAR USE ONLY Initial U.S. Approval: 2002

Approved
Approval ID

231e2433-31fe-4612-80f0-ba00dee3b26a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 17, 2011

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ARIPIPRAZOLE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-6280
Application NumberNDA021436
Product Classification
M
Marketing Category
C73594
G
Generic Name
ARIPIPRAZOLE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 22, 2011
FDA Product Classification

INGREDIENTS (10)

HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
ARIPIPRAZOLEActive
Quantity: 2 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT

ARIPIPRAZOLE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-5202
Application NumberNDA021436
Product Classification
M
Marketing Category
C73594
G
Generic Name
ARIPIPRAZOLE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 22, 2011
FDA Product Classification

INGREDIENTS (10)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ARIPIPRAZOLEActive
Quantity: 10 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT

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ABILIFY - FDA Drug Approval Details