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Deferasirox

These highlights do not include all the information needed to use DEFERASIROX TABLETS FOR ORAL SUSPENSION safely and effectively. See full prescribing information for DEFERASIROX TABLETS FOR ORAL SUSPENSION. DEFERASIROX tablets, for oral suspension Initial U.S. Approval: 2005

Approved
Approval ID

e365e748-4b61-94f2-fb7a-f81919eaccaa

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 30, 2020

Manufacturers
FDA

Dr. Reddy's Laboratories Inc

DUNS: 802315887

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 Code43598-854
Application NumberANDA209878
Product Classification
M
Marketing Category
C73584
G
Generic Name
Deferasirox
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2020
FDA Product Classification

INGREDIENTS (9)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
DEFERASIROXActive
Quantity: 500 mg in 1 1
Code: V8G4MOF2V9
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Deferasirox

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43598-856
Application NumberANDA209878
Product Classification
M
Marketing Category
C73584
G
Generic Name
Deferasirox
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2020
FDA Product Classification

INGREDIENTS (9)

DEFERASIROXActive
Quantity: 250 mg in 1 1
Code: V8G4MOF2V9
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Deferasirox

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43598-855
Application NumberANDA209878
Product Classification
M
Marketing Category
C73584
G
Generic Name
Deferasirox
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2020
FDA Product Classification

INGREDIENTS (9)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
DEFERASIROXActive
Quantity: 125 mg in 1 1
Code: V8G4MOF2V9
Classification: ACTIB

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Deferasirox - FDA Drug Approval Details