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
4cd07a3c-9673-4aa0-b76a-d79df2399ee1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 28, 2023
Manufacturers
FDA
Major Pharmaceuticals
DUNS: 191427277
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 Code0904-6467
Application NumberANDA076274
Product Classification
M
Marketing Category
C73584
G
Generic Name
clopidogrel bisulfate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 28, 2023
FDA Product Classification
INGREDIENTS (11)
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CLOPIDOGREL BISULFATEActive
Quantity: 300 mg in 1 1
Code: 08I79HTP27
Classification: ACTIM
METHYLCELLULOSE (15 MPA.S)Inactive
Code: NPU9M2E6L8
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
ZINC STEARATEInactive
Code: H92E6QA4FV
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYDROXYPROPYL CELLULOSE (70000 WAMW)Inactive
Code: 66O7AQV0RT
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT