Label: DUTASTERIDE capsule, liquid filled

  • NDC Code(s): 70771-1347-3, 70771-1347-9
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 21, 2020

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1347-3 in bottle of 30 capsules

     

    Dutasteride Capsules, 0.5 mg

     

    Rx only

     

    30 Capsules

     

     

    container label
  • INGREDIENTS AND APPEARANCE
    DUTASTERIDE 
    dutasteride capsule, liquid filled
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1347
    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)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALCOHOL (UNII: 3K9958V90M)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)  
    AMMONIA (UNII: 5138Q19F1X)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITE (OPAQUE-WHITE) Scoreno score
    ShapeCAPSULE (Oblong Shaped) Size20mm
    FlavorImprint Code 641
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1347-330 in 1 BOTTLE; Type 0: Not a Combination Product05/16/2018
    2NDC:70771-1347-990 in 1 BOTTLE; Type 0: Not a Combination Product05/16/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20437305/16/2018
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1347) , MANUFACTURE(70771-1347)