Plavix
These highlights do not include all the information needed to use PLAVIX safely and effectively. See full prescribing information for PLAVIX. PLAVIX (clopidogrel bisulfate) tablets Initial U.S. Approval: 1997
Approved
Approval ID
079ed521-3ff0-47fa-86d5-a336732056cc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 2010
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 Code53808-0763
Application NumberNDA020839
Product Classification
M
Marketing Category
C73594
G
Generic Name
clopidogrel bisulfate
Product Specifications
Route of AdministrationORAL
Effective DateJune 7, 2010
FDA Product Classification
INGREDIENTS (11)
CLOPIDOGREL BISULFATEActive
Quantity: 75 mg in 1 1
Code: 08I79HTP27
Classification: ACTIM
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT