Label: TAMOXIFEN CITRATE tablet, film coated

  • NDC Code(s): 70771-1184-1, 70771-1184-6, 70771-1184-8, 70771-1184-9, view more
    70771-1185-0, 70771-1185-1, 70771-1185-3, 70771-1185-6, 70771-1185-9
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 28, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1184-1 in bottle of 100 tablets

    Tamoxifen Citrate Tablets USP, 10 mg

    Rx Only

    100 tablets

    tamoxifen tablets

    NDC 70771-1185-1 in bottle of 100 tablets

    Tamoxifen Citrate Tablets USP, 20 mg

    Rx Only

    100 tablets

    tamoxifen tablets
  • INGREDIENTS AND APPEARANCE
    TAMOXIFEN CITRATE 
    tamoxifen citrate tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1184
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TAMOXIFEN CITRATE (UNII: 7FRV7310N6) (TAMOXIFEN - UNII:094ZI81Y45) TAMOXIFEN10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code 826
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1184-660 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2018
    2NDC:70771-1184-990 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2018
    3NDC:70771-1184-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2018
    4NDC:70771-1184-8180 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20669401/03/2018
    TAMOXIFEN CITRATE 
    tamoxifen citrate tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1185
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TAMOXIFEN CITRATE (UNII: 7FRV7310N6) (TAMOXIFEN - UNII:094ZI81Y45) TAMOXIFEN20 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size9mm
    FlavorImprint Code 827
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1185-330 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2018
    2NDC:70771-1185-660 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2018
    3NDC:70771-1185-990 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2018
    4NDC:70771-1185-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2018
    5NDC:70771-1185-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20669401/03/2018
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited863362789ANALYSIS(70771-1184, 70771-1185) , MANUFACTURE(70771-1184, 70771-1185)