Clopidogrel
These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
Approved
Approval ID
0d010775-1160-4b2e-a928-563a02edd191
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 19, 2022
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 123797875
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clopidogrel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-414
Application NumberANDA203751
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clopidogrel
Product Specifications
Route of AdministrationORAL
Effective DateNovember 19, 2022
FDA Product Classification
INGREDIENTS (13)
CLOPIDOGREL BISULFATEActive
Quantity: 75 mg in 1 1
Code: 08I79HTP27
Classification: ACTIM
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT