Label: DUTASTERIDE capsule, liquid filled

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

Drug Label Information

Updated January 17, 2020

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  • Storage and Handling

    Store at 15-25°C

  • PRINCIPAL DISPLAY PANEL

    NDC 0173-7077-00

    Dutasteride 0.5mg Capsules

    Store at 15-25°C

    Quantity 200 BLISTERS

    Dutasteride Export Label
  • INGREDIENTS AND APPEARANCE
    DUTASTERIDE 
    dutasteride capsule, liquid filled
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0173-7077
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DUTASTERIDE (UNII: O0J6XJN02I) (DUTASTERIDE - UNII:O0J6XJN02I) DUTASTERIDE0.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL CAPRYLOCAPRATE (UNII: U72Q2I8C85)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorREDScoreno score
    ShapeOVAL (soft gelatin capsule) Size19mm
    FlavorImprint Code GS;MUF
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0173-7077-0020 in 1 CARTON02/19/2015
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only02/19/2015
    Labeler - GlaxoSmithKline LLC (167380711)