Label: BRAFTOVI- encorafenib capsule

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated February 3, 2022

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  • PRINCIPAL DISPLAY PANEL - 50 mg Capsule Blister Pack

    EXP
    Lot

    BRAFTOVI® 50 mg

    capsules
    encorafenib

    Pierre Fabre Médicament

    XXXXX

    PRINCIPAL DISPLAY PANEL - 50 mg Capsule Blister Pack
  • PRINCIPAL DISPLAY PANEL - 50 mg Capsule Blister Pack Carton

    BRAFTOVI® 50 mg

    hard capsules

    encorafenib

    Oral use

    28 | hard capsules

    Pierre Fabre
    Médicament

    PRINCIPAL DISPLAY PANEL - 50 mg Capsule Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    BRAFTOVI 
    encorafenib capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70255-050
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENCORAFENIB (UNII: 8L7891MRB6) (ENCORAFENIB - UNII:8L7891MRB6) ENCORAFENIB50 mg
    Inactive Ingredients
    Ingredient NameStrength
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    POLOXAMER 188 (UNII: LQA7B6G8JG)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SUCCINIC ACID (UNII: AB6MNQ6J6L)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    SHELLAC (UNII: 46N107B71O)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorORANGE (Swedish) , PINK (Biege) Scoreno score
    ShapeCAPSULESize22mm
    FlavorImprint Code A;LGX;50mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70255-050-287 in 1 CARTON03/01/2022
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    EXPORT ONLY03/01/2022
    Labeler - Array BioPharma Inc. (004047838)