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
bb3b5e96-e629-4db5-8ad5-40c17c6dae18
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 8, 2023
Manufacturers
FDA
Westminster Pharmaceuticals, LLC
DUNS: 079516651
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clopidogrel Bisulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69367-200
Application NumberANDA204165
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clopidogrel Bisulfate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2023
FDA Product Classification
INGREDIENTS (10)
CLOPIDOGREL BISULFATEActive
Quantity: 75 mg in 1 1
Code: 08I79HTP27
Classification: ACTIM
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Clopidogrel Bisulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69367-194
Application NumberANDA204165
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clopidogrel Bisulfate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2023
FDA Product Classification
INGREDIENTS (10)
CLOPIDOGREL BISULFATEActive
Quantity: 300 mg in 1 1
Code: 08I79HTP27
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT