Label: CLOPIDOGREL tablet, film coated

  • NDC Code(s): 70771-1062-0, 70771-1062-3, 70771-1062-5, 70771-1062-9
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 18, 2020

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  • MEDICATION GUIDE

    Manufactured by:

    Cadila Healthcare Ltd.

    India.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1062-9 in bottle of 90 Tablets

    Clopidogrel Tablets USP, 75 mg

    Rx only

    90 TABLETS

    Clopidogrel Tablets, 75 mg
  • INGREDIENTS AND APPEARANCE
    CLOPIDOGREL 
    clopidogrel tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1062
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOPIDOGREL BISULFATE (UNII: 08I79HTP27) (CLOPIDOGREL - UNII:A74586SNO7) CLOPIDOGREL75 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorPINK (PINK) Scoreno score
    ShapeROUND (ROUND) Size9mm
    FlavorImprint Code 379
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1062-330 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2017
    2NDC:70771-1062-990 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2017
    3NDC:70771-1062-5500 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2017
    4NDC:70771-1062-01000 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20168602/08/2017
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1062) , MANUFACTURE(70771-1062)