Label: FESOTERODINE FUMARATE tablet, film coated, extended release

  • NDC Code(s): 70771-1168-2, 70771-1168-3, 70771-1168-4, 70771-1168-9, view more
    70771-1169-2, 70771-1169-3, 70771-1169-4, 70771-1169-9
  • 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 70771-1168-9 in bottle of 90 tablets

    Fesoterodine Fumarate Extended-release Tablets, 4 mg

    Rx only

    90 tablets

    Fesoterodine ER Tablets, 4 mg

    NDC 70771-1169-9 in bottle of 90 tablets

    Fesoterodine Fumarate Extended-release Tablets, 8 mg

    Rx only

    90 tablets

    Fesoterodine ER Tablets, 8 mg
  • INGREDIENTS AND APPEARANCE
    FESOTERODINE FUMARATE 
    fesoterodine fumarate tablet, film coated, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1168
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FESOTERODINE FUMARATE (UNII: EOS72165S7) (FESOTERODINE - UNII:621G617227) FESOTERODINE FUMARATE4 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    Product Characteristics
    ColorYELLOW (Light Yellow) Scoreno score
    ShapeOVAL (Oval) Size13mm
    FlavorImprint Code 479
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1168-330 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
    2NDC:70771-1168-990 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
    3NDC:70771-1168-410 in 1 CARTON12/07/2017
    3NDC:70771-1168-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20494612/07/2017
    FESOTERODINE FUMARATE 
    fesoterodine fumarate tablet, film coated, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1169
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FESOTERODINE FUMARATE (UNII: EOS72165S7) (FESOTERODINE - UNII:621G617227) FESOTERODINE FUMARATE8 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    Product Characteristics
    ColorWHITE (White to Off-White) Scoreno score
    ShapeOVAL (Oval) Size13mm
    FlavorImprint Code 480
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1169-330 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
    2NDC:70771-1169-990 in 1 BOTTLE; Type 0: Not a Combination Product12/07/2017
    3NDC:70771-1169-410 in 1 CARTON12/07/2017
    3NDC:70771-1169-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20494612/07/2017
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1168, 70771-1169) , MANUFACTURE(70771-1168, 70771-1169)