Clopidogrel
These highlights do not include all the information needed to use CLOPIDOGREL tablets, USP safely and effectively. See full prescribing information for CLOPIDOGREL tablets, USP. CLOPIDOGREL Tablets, USP for oral useInitial U.S. Approval: 1997
Approved
Approval ID
86ee71f2-850e-4c8e-87f3-c7a618d59d95
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 19, 2019
Manufacturers
FDA
Vensun Pharmaceuticals, Inc.
DUNS: 078310501
Products 2
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 Code42543-713
Application NumberANDA204165
Product Classification
M
Marketing Category
C73584
G
Generic Name
clopidogrel
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2019
FDA Product Classification
INGREDIENTS (10)
CLOPIDOGREL BISULFATEActive
Quantity: 75 mg in 1 1
Code: 08I79HTP27
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
clopidogrel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42543-714
Application NumberANDA204165
Product Classification
M
Marketing Category
C73584
G
Generic Name
clopidogrel
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2019
FDA Product Classification
INGREDIENTS (10)
CLOPIDOGREL BISULFATEActive
Quantity: 300 mg in 1 1
Code: 08I79HTP27
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT