Aripiprazole
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
Approved
Approval ID
573c6bb6-941f-4413-8c23-826025385864
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 11, 2023
Manufacturers
FDA
Major Pharmaceuticals
DUNS: 191427277
Products 6
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 Code0904-7368
Application NumberANDA204838
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2023
FDA Product Classification
INGREDIENTS (6)
ARIPIPRAZOLEActive
Quantity: 10 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
Aripiprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0904-7367
Application NumberANDA204838
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2023
FDA Product Classification
INGREDIENTS (6)
ARIPIPRAZOLEActive
Quantity: 5 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
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 Code0904-7371
Application NumberANDA204838
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2023
FDA Product Classification
INGREDIENTS (6)
ARIPIPRAZOLEActive
Quantity: 30 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
Aripiprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0904-7370
Application NumberANDA204838
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2023
FDA Product Classification
INGREDIENTS (5)
ARIPIPRAZOLEActive
Quantity: 20 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
Aripiprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0904-7366
Application NumberANDA204838
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2023
FDA Product Classification
INGREDIENTS (7)
ARIPIPRAZOLEActive
Quantity: 2 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
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 Code0904-7369
Application NumberANDA204838
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2023
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ARIPIPRAZOLEActive
Quantity: 15 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT