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
3988e66f-339c-451e-9f8a-9d0c0a2a381b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2024
Manufacturers
FDA
Torrent Pharmaceuticals Limited
DUNS: 916488547
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 Code13668-216
Application NumberANDA201519
Product Classification
M
Marketing Category
C73584
G
Generic Name
aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2023
FDA Product Classification
INGREDIENTS (8)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ARIPIPRAZOLEActive
Quantity: 2 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
aripiprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13668-220
Application NumberANDA201519
Product Classification
M
Marketing Category
C73584
G
Generic Name
aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2023
FDA Product Classification
INGREDIENTS (7)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
ARIPIPRAZOLEActive
Quantity: 20 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
aripiprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13668-221
Application NumberANDA201519
Product Classification
M
Marketing Category
C73584
G
Generic Name
aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2023
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ARIPIPRAZOLEActive
Quantity: 30 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
aripiprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13668-218
Application NumberANDA201519
Product Classification
M
Marketing Category
C73584
G
Generic Name
aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2023
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ARIPIPRAZOLEActive
Quantity: 10 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
aripiprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13668-217
Application NumberANDA201519
Product Classification
M
Marketing Category
C73584
G
Generic Name
aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2023
FDA Product Classification
INGREDIENTS (7)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ARIPIPRAZOLEActive
Quantity: 5 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
aripiprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13668-219
Application NumberANDA201519
Product Classification
M
Marketing Category
C73584
G
Generic Name
aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2023
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ARIPIPRAZOLEActive
Quantity: 15 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT