Label: BICALUTAMIDE tablet, film coated

  • NDC Code(s): 65841-613-01, 65841-613-05, 65841-613-06, 65841-613-10, view more
    65841-613-30
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 14, 2020

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-613-06 in bottle of 30 tablets

    Bicalutamide Tablets USP, 50 mg

    Rx only

    30 tablets

    Bicalutamide Tablets USP, 50 mg
  • INGREDIENTS AND APPEARANCE
    BICALUTAMIDE 
    bicalutamide tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-613
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BICALUTAMIDE (UNII: A0Z3NAU9DP) (BICALUTAMIDE - UNII:A0Z3NAU9DP) BICALUTAMIDE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF- WHITE) Scoreno score
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code ZE;57
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-613-0630 in 1 BOTTLE; Type 0: Not a Combination Product07/06/2009
    2NDC:65841-613-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/06/2009
    3NDC:65841-613-05500 in 1 BOTTLE; Type 0: Not a Combination Product07/06/2009
    4NDC:65841-613-101000 in 1 BOTTLE; Type 0: Not a Combination Product07/06/2009
    5NDC:65841-613-3010 in 1 CARTON07/06/2009
    510 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07908907/06/2009
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-613) , MANUFACTURE(65841-613)