DEFERASIROX- deferasirox tablet, for suspension 
Zydus Lifesciences Limited

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Deferasirox Tablets for Oral Suspension

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1409-3

Deferasirox Tablets for Oral Suspension, 125 mg

30 Tablets

Rx only

125 mg label

NDC 70771-1410-3

Deferasirox Tablets for Oral Suspension, 250 mg

30 Tablets

Rx only

250 mg label

NDC 70771-1411-3

Deferasirox Tablets for Oral Suspension, 500 mg

30 Tablets

Rx only

500 mg label
DEFERASIROX 
deferasirox tablet, for suspension
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1409
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEFERASIROX (UNII: V8G4MOF2V9) (DEFERASIROX - UNII:V8G4MOF2V9) DEFERASIROX125 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSPOVIDONE (UNII: 2S7830E561)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
ColorWHITE (WHITE TO OFF WHITE) Scoreno score
ShapeROUND (ROUND) Size12mm
FlavorImprint Code 1011
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1409-330 in 1 BOTTLE; Type 0: Not a Combination Product05/06/2021
2NDC:70771-1409-990 in 1 BOTTLE; Type 0: Not a Combination Product05/06/2021
3NDC:70771-1409-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/06/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20888205/06/2021
DEFERASIROX 
deferasirox tablet, for suspension
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1410
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEFERASIROX (UNII: V8G4MOF2V9) (DEFERASIROX - UNII:V8G4MOF2V9) DEFERASIROX250 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSPOVIDONE (UNII: 2S7830E561)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
ColorWHITE (WHITE TO OFF WHITE) Scoreno score
ShapeROUND (ROUND) Size15mm
FlavorImprint Code 1012
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1410-330 in 1 BOTTLE; Type 0: Not a Combination Product05/06/2021
2NDC:70771-1410-990 in 1 BOTTLE; Type 0: Not a Combination Product05/06/2021
3NDC:70771-1410-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/06/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20888205/06/2021
DEFERASIROX 
deferasirox tablet, for suspension
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1411
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEFERASIROX (UNII: V8G4MOF2V9) (DEFERASIROX - UNII:V8G4MOF2V9) DEFERASIROX500 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSPOVIDONE (UNII: 2S7830E561)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
ColorWHITE (WHITE TO OFF WHITE) Scoreno score
ShapeROUND (ROUND) Size18mm
FlavorImprint Code 1013
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1411-330 in 1 BOTTLE; Type 0: Not a Combination Product05/06/2021
2NDC:70771-1411-990 in 1 BOTTLE; Type 0: Not a Combination Product05/06/2021
3NDC:70771-1411-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/06/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20888205/06/2021
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (863362789)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1409, 70771-1410, 70771-1411) , MANUFACTURE(70771-1409, 70771-1410, 70771-1411)

Revised: 11/2024
Document Id: fd7b5eb6-d95c-4f57-aaa9-0abf6cfdb071
Set id: 8df9bad9-0be5-4dc1-b16d-8a1e8727d45c
Version: 4
Effective Time: 20241128
 
Zydus Lifesciences Limited