Label: FINASTERIDE tablet, film coated

  • NDC Code(s): 70771-1152-0, 70771-1152-1, 70771-1152-3, 70771-1152-4
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 26, 2020

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1152-0 in bottle of 1000 tablets

    Finasteride Tablets USP, 5 mg

    Rx only

    1000 tablets

    Finasteride Tablets, 5 mg
  • INGREDIENTS AND APPEARANCE
    FINASTERIDE 
    finasteride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1152
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FINASTERIDE (UNII: 57GNO57U7G) (FINASTERIDE - UNII:57GNO57U7G) FINASTERIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SHELLAC (UNII: 46N107B71O)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColorBLUE (blue) Scoreno score
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code ZE;56
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1152-330 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    2NDC:70771-1152-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    3NDC:70771-1152-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    4NDC:70771-1152-410 in 1 CARTON12/05/2017
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07890012/05/2017
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1152) , MANUFACTURE(70771-1152)