deferasirox
These highlights do not include all the information needed to use DEFERASIROX TABLETS safely and effectively. See full prescribing information for DEFERASIROX TABLETS. DEFERASIROX tablets, for oral useInitial U.S. Approval: 2005
Approved
Approval ID
31df70cb-f6a0-4cba-a02c-dc9fa6bd63bd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 2, 2021
Manufacturers
FDA
Cipla USA Inc.
DUNS: 078719707
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
deferasirox
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-392
Application NumberANDA211852
Product Classification
M
Marketing Category
C73584
G
Generic Name
deferasirox
Product Specifications
Route of AdministrationORAL
Effective DateNovember 2, 2021
FDA Product Classification
INGREDIENTS (12)
DEFERASIROXActive
Quantity: 180 mg in 1 1
Code: V8G4MOF2V9
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
deferasirox
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-391
Application NumberANDA211852
Product Classification
M
Marketing Category
C73584
G
Generic Name
deferasirox
Product Specifications
Route of AdministrationORAL
Effective DateNovember 2, 2021
FDA Product Classification
INGREDIENTS (12)
DEFERASIROXActive
Quantity: 90 mg in 1 1
Code: V8G4MOF2V9
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
deferasirox
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-393
Application NumberANDA211852
Product Classification
M
Marketing Category
C73584
G
Generic Name
deferasirox
Product Specifications
Route of AdministrationORAL
Effective DateNovember 2, 2021
FDA Product Classification
INGREDIENTS (12)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DEFERASIROXActive
Quantity: 360 mg in 1 1
Code: V8G4MOF2V9
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT