Label: SOLIFENACIN tablet, film coated

  • NDC Code(s): 70771-1604-3, 70771-1604-9, 70771-1605-3, 70771-1605-9
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 26, 2020

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1604-3

    Solifenacin succinate tablets, 5 mg

    Rx only

    30 tablets

    5 mg

    NDC 70771-1605-3

    Solifenacin succinate tablets, 10 mg

    Rx only

    30 tablets

    10 mg
  • INGREDIENTS AND APPEARANCE
    SOLIFENACIN 
    solifenacin tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1604
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SOLIFENACIN SUCCINATE (UNII: KKA5DLD701) (SOLIFENACIN - UNII:A8910SQJ1U) SOLIFENACIN SUCCINATE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorYELLOW (LIGHT YELLOW) Scoreno score
    ShapeROUND (BICONVEX) Size8mm
    FlavorImprint Code 987
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1604-330 in 1 BOTTLE; Type 0: Not a Combination Product02/10/2022
    2NDC:70771-1604-990 in 1 BOTTLE; Type 0: Not a Combination Product02/10/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20772102/10/2022
    SOLIFENACIN 
    solifenacin tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1605
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SOLIFENACIN SUCCINATE (UNII: KKA5DLD701) (SOLIFENACIN - UNII:A8910SQJ1U) SOLIFENACIN SUCCINATE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Product Characteristics
    ColorWHITE (LIGHT PINK) Scoreno score
    ShapeROUND (BICONVEX) Size8mm
    FlavorImprint Code 988
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1605-990 in 1 BOTTLE; Type 0: Not a Combination Product02/10/2022
    2NDC:70771-1605-330 in 1 BOTTLE; Type 0: Not a Combination Product02/10/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20772102/10/2022
    Labeler - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited863362789ANALYSIS(70771-1604, 70771-1605) , MANUFACTURE(70771-1604, 70771-1605)