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
c1215d0c-a74f-218c-e053-2995a90ad46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 29, 2021
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
Products 1
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 Code68071-2394
Application NumberANDA207105
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateApril 29, 2021
FDA Product Classification
INGREDIENTS (7)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ARIPIPRAZOLEActive
Quantity: 10 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT