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
4af5bc9e-3e09-4dfd-8cc8-7677953c9c7c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 24, 2023
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
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 Code70710-1277
Application NumberANDA211383
Product Classification
M
Marketing Category
C73584
G
Generic Name
deferasirox
Product Specifications
Route of AdministrationORAL
Effective DateJuly 24, 2023
FDA Product Classification
INGREDIENTS (13)
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
DEFERASIROXActive
Quantity: 360 mg in 1 1
Code: V8G4MOF2V9
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
deferasirox
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70710-1275
Application NumberANDA211383
Product Classification
M
Marketing Category
C73584
G
Generic Name
deferasirox
Product Specifications
Route of AdministrationORAL
Effective DateJuly 24, 2023
FDA Product Classification
INGREDIENTS (11)
DEFERASIROXActive
Quantity: 90 mg in 1 1
Code: V8G4MOF2V9
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
deferasirox
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70710-1276
Application NumberANDA211383
Product Classification
M
Marketing Category
C73584
G
Generic Name
deferasirox
Product Specifications
Route of AdministrationORAL
Effective DateJuly 24, 2023
FDA Product Classification
INGREDIENTS (13)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DEFERASIROXActive
Quantity: 180 mg in 1 1
Code: V8G4MOF2V9
Classification: ACTIB
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT