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 use Initial U.S. Approval: 2005
Approved
Approval ID
53e645f5-3b29-4c9c-a620-b14f85be5ad4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 12, 2022
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
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 Code57664-770
Application NumberANDA211641
Product Classification
M
Marketing Category
C73584
G
Generic Name
DEFERASIROX
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2022
FDA Product Classification
INGREDIENTS (12)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
HYPROMELLOSE 2910 (10000 MPA.S)Inactive
Code: 0HO1H52958
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DEFERASIROXActive
Quantity: 360 mg in 1 1
Code: V8G4MOF2V9
Classification: ACTIB
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
DEFERASIROX
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57664-769
Application NumberANDA211641
Product Classification
M
Marketing Category
C73584
G
Generic Name
DEFERASIROX
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2022
FDA Product Classification
INGREDIENTS (12)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
HYPROMELLOSE 2910 (10000 MPA.S)Inactive
Code: 0HO1H52958
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
DEFERASIROXActive
Quantity: 180 mg in 1 1
Code: V8G4MOF2V9
Classification: ACTIB
DEFERASIROX
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57664-768
Application NumberANDA211641
Product Classification
M
Marketing Category
C73584
G
Generic Name
DEFERASIROX
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2022
FDA Product Classification
INGREDIENTS (12)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
HYPROMELLOSE 2910 (10000 MPA.S)Inactive
Code: 0HO1H52958
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DEFERASIROXActive
Quantity: 90 mg in 1 1
Code: V8G4MOF2V9
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT