Clopidogrel
These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely andeffectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral useInitial U.S. Approval: 1997
Approved
Approval ID
3dd041b8-abf7-4e19-96bb-b3cc8b5603b5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2019
Manufacturers
FDA
International Laboratories, LLC
DUNS: 023569924
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 Code54458-888
Application NumberANDA076999
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clopidogrel
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2019
FDA Product Classification
INGREDIENTS (15)
CLOPIDOGREL BISULFATEActive
Quantity: 75 mg in 1 1
Code: 08I79HTP27
Classification: ACTIM
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
INDIGOTINDISULFONATE SODIUMInactive
Code: D3741U8K7L
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT