Clopidogrel bisulfate
CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
Approved
Approval ID
b5aa951f-72de-bea1-98a2-a4085c64a361
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2022
Manufacturers
FDA
Dr.Reddy's Laboratories Limited
DUNS: 650562841
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 Code55111-196
Application NumberANDA076273
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clopidogrel bisulfate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2022
FDA Product Classification
INGREDIENTS (9)
Clopidogrel bisulfateActive
Quantity: 75 mg in 1 1
Code: 08I79HTP27
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
MannitolInactive
Code: 3OWL53L36A
Classification: IACT
Hypromellose 2910 (5 Mpa.S)Inactive
Code: R75537T0T4
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Polyethylene Glycol 400Inactive
Code: B697894SGQ
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT