Label: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE tablet, film coated

  • NDC Code(s): 70771-1594-2, 70771-1594-3, 70771-1594-4, 70771-1594-9
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 4, 2021

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1594-3

    Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg

    Rx Only

    30 tablets

    label
  • INGREDIENTS AND APPEARANCE
    EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 
    emtricitabine and tenofovir disoproxil fumarate tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1594
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EMTRICITABINE (UNII: G70B4ETF4S) (EMTRICITABINE - UNII:G70B4ETF4S) EMTRICITABINE200 mg
    TENOFOVIR DISOPROXIL FUMARATE (UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5) TENOFOVIR DISOPROXIL FUMARATE300 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    GLYCERYL MONOCAPRYLOCAPRATE (UNII: G7515SW10N)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    KAOLIN (UNII: 24H4NWX5CO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code 1367
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1594-330 in 1 BOTTLE; Type 0: Not a Combination Product03/24/2021
    2NDC:70771-1594-990 in 1 BOTTLE; Type 0: Not a Combination Product03/24/2021
    3NDC:70771-1594-410 in 1 CARTON03/24/2021
    3NDC:70771-1594-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21268903/24/2021
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (863362789)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited863362789ANALYSIS(70771-1594) , MANUFACTURE(70771-1594)