DEFERASIROX tablet, for suspension

DEFERASIROX by

Drug Labeling and Warnings

DEFERASIROX by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70771-1409-3

Deferasirox Tablets for Oral Suspension, 125 mg

30 Tablets

Rx only

NDC: 70771-1410-3

Deferasirox Tablets for Oral Suspension, 250 mg

30 Tablets

Rx only

NDC: 70771-1411-3

Deferasirox Tablets for Oral Suspension, 500 mg

30 Tablets

Rx only

INGREDIENTS AND APPEARANCE

DEFERASIROX 
deferasirox tablet, for suspension

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1409
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEFERASIROX (UNII: V8G4MOF2V9) (DEFERASIROX - UNII:V8G4MOF2V9)	DEFERASIROX	125 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (WHITE TO OFF WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	12mm
Flavor		Imprint Code	1011
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1409-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2021
2	NDC: 70771-1409-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2021
3	NDC: 70771-1409-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA208882	05/06/2021

DEFERASIROX 
deferasirox tablet, for suspension

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1410
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEFERASIROX (UNII: V8G4MOF2V9) (DEFERASIROX - UNII:V8G4MOF2V9)	DEFERASIROX	250 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (WHITE TO OFF WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	15mm
Flavor		Imprint Code	1012
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1410-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2021
2	NDC: 70771-1410-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2021
3	NDC: 70771-1410-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA208882	05/06/2021

DEFERASIROX 
deferasirox tablet, for suspension

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1411
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEFERASIROX (UNII: V8G4MOF2V9) (DEFERASIROX - UNII:V8G4MOF2V9)	DEFERASIROX	500 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (WHITE TO OFF WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	18mm
Flavor		Imprint Code	1013
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1411-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2021
2	NDC: 70771-1411-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2021
3	NDC: 70771-1411-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA208882	05/06/2021

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (863362789)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1409, 70771-1410, 70771-1411) , MANUFACTURE(70771-1409, 70771-1410, 70771-1411)