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
95954ba3-e838-4dd7-aef1-c51ac6aff76b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 6, 2020
Manufacturers
FDA
ScieGen Pharmaceuticals Inc
DUNS: 079391286
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 Code50228-325
Application NumberANDA206383
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateMarch 7, 2020
FDA Product Classification
INGREDIENTS (9)
ARIPIPRAZOLEActive
Quantity: 5 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
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 Code50228-326
Application NumberANDA206383
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateMarch 7, 2020
FDA Product Classification
INGREDIENTS (10)
ARIPIPRAZOLEActive
Quantity: 10 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
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 Code50228-328
Application NumberANDA206383
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateMarch 7, 2020
FDA Product Classification
INGREDIENTS (10)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
ARIPIPRAZOLEActive
Quantity: 20 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Aripiprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50228-329
Application NumberANDA206383
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateMarch 7, 2020
FDA Product Classification
INGREDIENTS (10)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ARIPIPRAZOLEActive
Quantity: 30 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
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 Code50228-327
Application NumberANDA206383
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateMarch 7, 2020
FDA Product Classification
INGREDIENTS (10)
ARIPIPRAZOLEActive
Quantity: 15 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
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 Code50228-324
Application NumberANDA206383
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateMarch 7, 2020
FDA Product Classification
INGREDIENTS (10)
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ARIPIPRAZOLEActive
Quantity: 2 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT