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
217e52b5-3a7b-4bbe-af3c-b18de7d426c3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2010
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
Products 4
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 Code21695-005
Application NumberNDA021436
Product Classification
M
Marketing Category
C73594
G
Generic Name
ARIPIPRAZOLE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2008
FDA Product Classification
INGREDIENTS (10)
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ARIPIPRAZOLEActive
Quantity: 20 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
ARIPIPRAZOLE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-004
Application NumberNDA021436
Product Classification
M
Marketing Category
C73594
G
Generic Name
ARIPIPRAZOLE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2008
FDA Product Classification
INGREDIENTS (10)
ARIPIPRAZOLEActive
Quantity: 15 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
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
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
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 Code21695-003
Application NumberNDA021436
Product Classification
M
Marketing Category
C73594
G
Generic Name
ARIPIPRAZOLE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2008
FDA Product Classification
INGREDIENTS (10)
ARIPIPRAZOLEActive
Quantity: 10 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
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
ARIPIPRAZOLE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-002
Application NumberNDA021436
Product Classification
M
Marketing Category
C73594
G
Generic Name
ARIPIPRAZOLE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2008
FDA Product Classification
INGREDIENTS (10)
ARIPIPRAZOLEActive
Quantity: 5 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT