Clopidogrel

Basic Information

Product Name

Clopidogrel

FDA Product Code

70518-0400

Regulatory Information

NDC Product Code

70518-0400

Application Number

ANDA202928

Marketing Category

C73584

Effective Date

January 5, 2024

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED

Code: 2165RE0K14

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

DIMETHICONE

Code: 92RU3N3Y1O

Class Code: IACT

CASTOR OIL

Code: D5340Y2I9G

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

CLOPIDOGREL BISULFATE

Quantity: 75 mg in 1 1

Code: 08I79HTP27

Class Code: ACTIM

Active Moieties

Code: A74586SNO7

Clopidogrel

Basic Information

Regulatory Information

Company Information

Active Ingredients

LACTOSE MONOHYDRATE

HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED

SILICON DIOXIDE

DIMETHICONE

CASTOR OIL

HYPROMELLOSES

POLYETHYLENE GLYCOL, UNSPECIFIED

TITANIUM DIOXIDE

FERRIC OXIDE RED

Active Moieties

CLOPIDOGREL