Aripiprazole
These highlights do not include all the information needed to use ARIPIPRAZOLE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE ORALLY DISINTEGRATING TABLETS. ARIPIPRAZOLE orally disintegrating tablets Initial U.S. Approval: 2002
Approved
Approval ID
4bcfd5a7-bec7-4426-9314-17daaf715cad
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2023
Manufacturers
FDA
ScieGen Pharmaceuticals Inc
DUNS: 079391286
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Aripiprazole orally disintegrating
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50228-330
Application NumberANDA207240
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole orally disintegrating
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2023
FDA Product Classification
INGREDIENTS (12)
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
VANILLAInactive
Code: Q74T35078H
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
ARIPIPRAZOLEActive
Quantity: 10 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Aripiprazole orally disintegrating
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50228-331
Application NumberANDA207240
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole orally disintegrating
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2023
FDA Product Classification
INGREDIENTS (12)
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
VANILLAInactive
Code: Q74T35078H
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
ARIPIPRAZOLEActive
Quantity: 15 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB