VARDENAFIL TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]

VARDENAFIL TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]
PDF | XML

NDC 70771-1047-1, 70771-1047-3, 70771-1047-9, 70771-1048-1, 70771-1048-3, 70771-1048-9, 70771-1049-1, 70771-1049-3, 70771-1049-9, 70771-1050-1, 70771-1050-3, 70771-1050-9
Set ID 8ea14f7e-44a0-4d9c-968a-87b97ca12f09
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Cadila Healthcare Limited
Generic Name
Product Class
Product Number
Application Number ANDA208960
  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1047-3

    Vardenafil Tablets, 2.5 mg

    30 Tablets

    Rx only

    Vardenafil Tablets

    NDC 70771-1048-3

    Vardenafil Tablets, 5 mg

    30 Tablets

    Rx only

    Vardenafil Tablets

    NDC 70771-1049-3

    Vardenafil Tablets, 10 mg

    30 Tablets

    Rx only

    Vardenafil Tablets

    NDC 70771-1050-3

    Vardenafil Tablets, 20 mg

    30 Tablets

    Rx only

    Vardenafil Tablets
  • INGREDIENTS AND APPEARANCE
    VARDENAFIL 
    vardenafil tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1047
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VARDENAFIL HYDROCHLORIDE TRIHYDRATE (UNII: 5M8S2CU0TS) (VARDENAFIL - UNII:UCE6F4125H) VARDENAFIL2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size5mm
    FlavorImprint Code 10;68
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1047-330 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2018
    2NDC:70771-1047-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2018
    3NDC:70771-1047-990 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20896011/01/2018
    VARDENAFIL 
    vardenafil tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1048
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VARDENAFIL HYDROCHLORIDE TRIHYDRATE (UNII: 5M8S2CU0TS) (VARDENAFIL - UNII:UCE6F4125H) VARDENAFIL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorYELLOW (LIGHT YELLOW) Scoreno score
    ShapeROUND (ROUND) Size5mm
    FlavorImprint Code 10;69
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1048-330 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2018
    2NDC:70771-1048-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2018
    3NDC:70771-1048-990 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20896011/01/2018
    VARDENAFIL 
    vardenafil tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1049
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VARDENAFIL HYDROCHLORIDE TRIHYDRATE (UNII: 5M8S2CU0TS) (VARDENAFIL - UNII:UCE6F4125H) VARDENAFIL10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorYELLOW (LIGHT YELLOW TO ORANGE) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code 10;70
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1049-990 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2018
    2NDC:70771-1049-330 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2018
    3NDC:70771-1049-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20896011/01/2018
    VARDENAFIL 
    vardenafil tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1050
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VARDENAFIL HYDROCHLORIDE TRIHYDRATE (UNII: 5M8S2CU0TS) (VARDENAFIL - UNII:UCE6F4125H) VARDENAFIL20 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorYELLOW (LIGHT YELLOW TO ORANGE) Scoreno score
    ShapeROUND (ROUND) Size8mm
    FlavorImprint Code 10;71
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1050-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2018
    2NDC:70771-1050-330 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2018
    3NDC:70771-1050-990 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20896011/01/2018
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (863362789)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited863362789ANALYSIS(70771-1047, 70771-1048, 70771-1049, 70771-1050) , MANUFACTURE(70771-1047, 70771-1048, 70771-1049, 70771-1050)

Related Drugs