Label: FEBUXOSTAT tablet

  • NDC Code(s): 70771-1552-0, 70771-1552-1, 70771-1552-3, 70771-1552-4, view more
    70771-1552-5, 70771-1552-9, 70771-1553-0, 70771-1553-1, 70771-1553-3, 70771-1553-4, 70771-1553-5, 70771-1553-9
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 4, 2023

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  • SPL UNCLASSIFIED SECTION

  • SPL MEDGUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Febuxostat Tablets, 40 mg – 30's count

    NDC- 70771-1552-3

    40 mg label

    Febuxostat Tablets, 80 mg – 30's count

    NDC- 70771-1553-3

    80 mg label
  • INGREDIENTS AND APPEARANCE
    FEBUXOSTAT 
    febuxostat tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1552
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FEBUXOSTAT (UNII: 101V0R1N2E) (FEBUXOSTAT - UNII:101V0R1N2E) FEBUXOSTAT40 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeOVAL (OVAL) Size13mm
    FlavorImprint Code 401
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1552-330 in 1 BOTTLE; Type 0: Not a Combination Product03/31/2023
    2NDC:70771-1552-990 in 1 BOTTLE; Type 0: Not a Combination Product03/31/2023
    3NDC:70771-1552-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/31/2023
    4NDC:70771-1552-5500 in 1 BOTTLE; Type 0: Not a Combination Product03/31/2023
    5NDC:70771-1552-01000 in 1 BOTTLE; Type 0: Not a Combination Product03/31/2023
    6NDC:70771-1552-410 in 1 CARTON03/31/2023
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20544303/31/2023
    FEBUXOSTAT 
    febuxostat tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1553
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FEBUXOSTAT (UNII: 101V0R1N2E) (FEBUXOSTAT - UNII:101V0R1N2E) FEBUXOSTAT80 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size12mm
    FlavorImprint Code 402
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1553-330 in 1 BOTTLE; Type 0: Not a Combination Product03/31/2023
    2NDC:70771-1553-990 in 1 BOTTLE; Type 0: Not a Combination Product03/31/2023
    3NDC:70771-1553-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/31/2023
    4NDC:70771-1553-5500 in 1 BOTTLE; Type 0: Not a Combination Product03/31/2023
    5NDC:70771-1553-01000 in 1 BOTTLE; Type 0: Not a Combination Product03/31/2023
    6NDC:70771-1553-410 in 1 CARTON03/31/2023
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20544303/31/2023
    Labeler - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(70771-1552, 70771-1553) , MANUFACTURE(70771-1552, 70771-1553)
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