Label: ENTECAVIR tablet, film coated

  • NDC Code(s): 70771-1019-1, 70771-1019-2, 70771-1019-3, 70771-1019-4, view more
    70771-1019-9, 70771-1020-1, 70771-1020-2, 70771-1020-3, 70771-1020-4, 70771-1020-9
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 31, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1019-3

    Entecavir Tablets USP, 0.5 mg

    Rx Only

    30 tablets

    Entecavir tablets

    NDC 70771-1020-3

    Entecavir Tablets USP, 1 mg

    Rx Only

    30 tablets

    Entecavir tablets
  • INGREDIENTS AND APPEARANCE
    ENTECAVIR 
    entecavir tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1019
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENTECAVIR (UNII: 5968Y6H45M) (ENTECAVIR ANHYDROUS - UNII:NNU2O4609D) ENTECAVIR0.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size8mm
    FlavorImprint Code 920
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1019-330 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
    2NDC:70771-1019-990 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
    3NDC:70771-1019-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
    4NDC:70771-1019-410 in 1 CARTON08/10/2017
    4NDC:70771-1019-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20674508/10/2017
    ENTECAVIR 
    entecavir tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1020
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENTECAVIR (UNII: 5968Y6H45M) (ENTECAVIR ANHYDROUS - UNII:NNU2O4609D) ENTECAVIR1 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorPINK (LIGHT-PINK TO PINK) Scoreno score
    ShapeROUND (ROUND) Size10mm
    FlavorImprint Code 921
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1020-330 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
    2NDC:70771-1020-990 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
    3NDC:70771-1020-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2017
    4NDC:70771-1020-410 in 1 CARTON08/10/2017
    4NDC:70771-1020-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20674508/10/2017
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited863362789ANALYSIS(70771-1019, 70771-1020) , MANUFACTURE(70771-1019, 70771-1020)