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
d8275c2d-f42d-4f32-aa9f-03a202c8e99f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 16, 2012
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 1
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 Code52959-604
Application NumberNDA021436
Product Classification
M
Marketing Category
C73594
G
Generic Name
ARIPIPRAZOLE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 13, 2012
FDA Product Classification
INGREDIENTS (10)
ARIPIPRAZOLEActive
Quantity: 5 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT