DEFERASIROX- deferasirox tablet, film coated 
Zydus Lifesciences Limited

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DEFERASIROX TABLETS

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
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)

Revised: 9/2023
Document Id: ba8b0a29-7725-46a5-9c73-95d1d3876195
Set id: fcd2ffe2-c8ba-400b-b7f9-e0e4b3510b98
Version: 5
Effective Time: 20230921
 
Zydus Lifesciences Limited