clopidogrel bisulfate
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
9036093d-8957-472d-916b-1425d38da373
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 17, 2017
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
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 Code43353-269
Application NumberANDA076274
Product Classification
M
Marketing Category
C73584
G
Generic Name
clopidogrel bisulfate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 18, 2017
FDA Product Classification
INGREDIENTS (11)
CLOPIDOGREL BISULFATEActive
Quantity: 75 mg in 1 1
Code: 08I79HTP27
Classification: ACTIM
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
METHYLCELLULOSE (15 MPA.S)Inactive
Code: NPU9M2E6L8
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSE (1200000 MW)Inactive
Code: RFW2ET671P
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
ZINC STEARATEInactive
Code: H92E6QA4FV
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT