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
3c8c68ca-aa48-43f0-977d-2608e1666be4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-6567
Application NumberANDA202928
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clopidogrel
Product Specifications
Route of AdministrationORAL
Effective DateApril 26, 2023
FDA Product Classification
INGREDIENTS (10)
CLOPIDOGREL BISULFATEActive
Quantity: 75 mg in 1 1
Code: 08I79HTP27
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT