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
97d95498-f430-4647-90fe-eb27a2fa212e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 2022
Manufacturers
FDA
Safecor Health, LLC
DUNS: 828269675
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 Code48433-118
Application NumberANDA078583
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2019
FDA Product Classification
INGREDIENTS (6)
AripiprazoleActive
Quantity: 15 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
Tartaric AcidInactive
Code: W4888I119H
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Aripiprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code48433-115
Application NumberANDA078583
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2019
FDA Product Classification
INGREDIENTS (7)
AripiprazoleActive
Quantity: 2 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Tartaric AcidInactive
Code: W4888I119H
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
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 Code48433-120
Application NumberANDA078583
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2019
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
AripiprazoleActive
Quantity: 30 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
Tartaric AcidInactive
Code: W4888I119H
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Aripiprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code48433-117
Application NumberANDA078583
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2019
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
AripiprazoleActive
Quantity: 10 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Tartaric AcidInactive
Code: W4888I119H
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
Aripiprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code48433-119
Application NumberANDA078583
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2019
FDA Product Classification
INGREDIENTS (5)
AripiprazoleActive
Quantity: 20 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Tartaric AcidInactive
Code: W4888I119H
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
Aripiprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code48433-116
Application NumberANDA078583
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2019
FDA Product Classification
INGREDIENTS (6)
Tartaric AcidInactive
Code: W4888I119H
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
AripiprazoleActive
Quantity: 5 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT