Clopidogrel
These highlights do not include all the information needed to use clopidogrel bisulfate safely and effectively. See full prescribing information for clopidogrel tablets, USP. Clopidogrel Tablets, USPInitial U.S. Approval: 1997
Approved
Approval ID
e3136829-54e8-40bc-80e5-73038f478c3b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 9, 2013
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 1
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 Code53808-0616
Application NumberANDA090540
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clopidogrel Bisulfate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2013
FDA Product Classification
INGREDIENTS (12)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CLOPIDOGREL BISULFATEActive
Quantity: 75 mg in 1 1
Code: 08I79HTP27
Classification: ACTIM
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT