Label: DEFERASIROX tablet, film coated

  • NDC Code(s): 70771-1471-1, 70771-1471-3, 70771-1472-1, 70771-1472-3, view more
    70771-1473-1, 70771-1473-3
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 21, 2023

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  • MEDICATION GUIDE

  • SPL MEDGUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1471-3

    Deferasirox tablets, 90 mg

    30 Tablets

    Rx only

    Deferasirox tablets

    NDC 70771-1472-3

    Deferasirox tablets, 180 mg

    30 Tablets

    Rx only

    image

    NDC 70771-1473-3

    Deferasirox tablets, 360 mg

    30 Tablets

    Rx only

    Deferasirox tablets
  • INGREDIENTS AND APPEARANCE
    DEFERASIROX 
    deferasirox tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1471
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEFERASIROX (UNII: V8G4MOF2V9) (DEFERASIROX - UNII:V8G4MOF2V9) DEFERASIROX90 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (off-white) Scoreno score
    ShapeOVALSize11mm
    FlavorImprint Code 1275
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1471-330 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2019
    2NDC:70771-1471-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21138311/21/2019
    DEFERASIROX 
    deferasirox tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1473
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEFERASIROX (UNII: V8G4MOF2V9) (DEFERASIROX - UNII:V8G4MOF2V9) DEFERASIROX360 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 1277
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1473-330 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2019
    2NDC:70771-1473-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21138311/21/2019
    DEFERASIROX 
    deferasirox tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1472
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEFERASIROX (UNII: V8G4MOF2V9) (DEFERASIROX - UNII:V8G4MOF2V9) DEFERASIROX180 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUE (light blue) Scoreno score
    ShapeOVALSize14mm
    FlavorImprint Code 1276
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1472-330 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
    2NDC:70771-1472-1100 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21138306/16/2020
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited863362789ANALYSIS(70771-1471, 70771-1472, 70771-1473) , MANUFACTURE(70771-1471, 70771-1472, 70771-1473)
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