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
d0f910b5-adef-4a93-9369-70f1ed541503
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 20, 2023
Manufacturers
FDA
Ajanta Pharma USA Inc.
DUNS: 557554156
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 Code27241-053
Application NumberANDA206174
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateJuly 20, 2023
FDA Product Classification
INGREDIENTS (8)
AripiprazoleActive
Quantity: 10 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
hydroxypropyl cellulose (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
hydroxypropyl cellulose, low substitutedInactive
Code: 2165RE0K14
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
Aripiprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27241-056
Application NumberANDA206174
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateJuly 20, 2023
FDA Product Classification
INGREDIENTS (8)
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
AripiprazoleActive
Quantity: 30 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
hydroxypropyl cellulose (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
hydroxypropyl cellulose, low substitutedInactive
Code: 2165RE0K14
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
Aripiprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27241-054
Application NumberANDA206174
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateJuly 20, 2023
FDA Product Classification
INGREDIENTS (8)
AripiprazoleActive
Quantity: 15 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
hydroxypropyl cellulose (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
hydroxypropyl cellulose, low substitutedInactive
Code: 2165RE0K14
Classification: IACT
Aripiprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27241-052
Application NumberANDA206174
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateJuly 20, 2023
FDA Product Classification
INGREDIENTS (8)
AripiprazoleActive
Quantity: 5 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
hydroxypropyl cellulose (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
hydroxypropyl cellulose, low substitutedInactive
Code: 2165RE0K14
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
Aripiprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27241-055
Application NumberANDA206174
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateJuly 20, 2023
FDA Product Classification
INGREDIENTS (8)
hydroxypropyl cellulose (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
hydroxypropyl cellulose, low substitutedInactive
Code: 2165RE0K14
Classification: IACT
AripiprazoleActive
Quantity: 20 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
Aripiprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27241-051
Application NumberANDA206174
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateJuly 20, 2023
FDA Product Classification
INGREDIENTS (7)
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
AripiprazoleActive
Quantity: 2 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
hydroxypropyl cellulose, low substitutedInactive
Code: 2165RE0K14
Classification: IACT
hydroxypropyl cellulose (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT