Label: TADALAFIL tablet, film coated

  • NDC Code(s): 70771-1475-0, 70771-1475-1, 70771-1475-3, 70771-1475-4, view more
    70771-1475-5, 70771-1475-9, 70771-1476-0, 70771-1476-1, 70771-1476-3, 70771-1476-4, 70771-1476-5, 70771-1476-7, 70771-1476-9, 70771-1477-0, 70771-1477-1, 70771-1477-3, 70771-1477-4, 70771-1477-5, 70771-1477-9, 70771-1478-0, 70771-1478-1, 70771-1478-3, 70771-1478-4, 70771-1478-5, 70771-1478-9
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 31, 2022

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1475-3 in bottle of 30 tablets

    Tadalafil Tablets USP, 2.5 mg

    Rx Only

    30 tablets

    2.5 mg label

    NDC 70771-1476-3 in bottle of 30 tablets

    Tadalafil Tablets USP, 5 mg

    Rx Only

    30 tablets

    5 mg

    NDC 70771-1477-3 in bottle of 30 tablets

    Tadalafil Tablets USP, 10 mg

    Rx Only

    30 tablets

    10 mg

    NDC 70771-1478-3 in bottle of 30 tablets

    Tadalafil Tablets USP, 20 mg

    Rx Only

    30 tablets

    20 mg
  • INGREDIENTS AND APPEARANCE
    TADALAFIL 
    tadalafil tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1475
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TADALAFIL (UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT) TADALAFIL2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorWHITE (WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size6mm
    FlavorImprint Code T;1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1475-330 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
    2NDC:70771-1475-990 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
    3NDC:70771-1475-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
    4NDC:70771-1475-5500 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
    5NDC:70771-1475-01000 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
    6NDC:70771-1475-42 in 1 CARTON03/27/2019
    615 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20669303/27/2019
    TADALAFIL 
    tadalafil tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1477
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TADALAFIL (UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT) TADALAFIL10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorYELLOW (YELLOW) Scoreno score
    ShapeCAPSULE (CAPSULE) Size10mm
    FlavorImprint Code 898
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1477-330 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
    2NDC:70771-1477-990 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
    3NDC:70771-1477-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
    4NDC:70771-1477-5500 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
    5NDC:70771-1477-01000 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
    6NDC:70771-1477-42 in 1 CARTON03/27/2019
    615 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20669303/27/2019
    TADALAFIL 
    tadalafil tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1478
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TADALAFIL (UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT) TADALAFIL20 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorYELLOW (YELLOW) Scoreno score
    ShapeOVAL (OVAL) Size13mm
    FlavorImprint Code 899
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1478-330 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
    2NDC:70771-1478-990 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
    3NDC:70771-1478-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
    4NDC:70771-1478-5500 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
    5NDC:70771-1478-01000 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
    6NDC:70771-1478-42 in 1 CARTON03/27/2019
    615 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20669303/27/2019
    TADALAFIL 
    tadalafil tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1476
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TADALAFIL (UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT) TADALAFIL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorYELLOW (YELLOW) Scoreno score
    ShapeOVAL (OVAL) Size8mm
    FlavorImprint Code 897
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1476-710 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
    2NDC:70771-1476-330 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
    3NDC:70771-1476-990 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
    4NDC:70771-1476-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
    5NDC:70771-1476-5500 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
    6NDC:70771-1476-01000 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
    7NDC:70771-1476-42 in 1 CARTON03/27/2019
    715 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20669303/27/2019
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(70771-1475, 70771-1476, 70771-1477, 70771-1478) , MANUFACTURE(70771-1475, 70771-1476, 70771-1477, 70771-1478)
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