Deferiprone

Basic Information

Product Name

Deferiprone

FDA Product Code

0054-0711

Regulatory Information

NDC Product Code

0054-0711

Application Number

ANDA213239

Marketing Category

C73584

Effective Date

August 1, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use DEFERIPRONE TABLETS safely and effectively. See full prescribing information for DEFERIPRONE TABLETS.DEFERIPRONE tablets, for oral useInitial U.S. Approval: 2011

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

DEFERIPRONE

Quantity: 1000 mg in 1 1

Code: 2BTY8KH53L

Class Code: ACTIB

METHYLCELLULOSE (15 MPA.S)

Code: NPU9M2E6L8

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POLYETHYLENE GLYCOL 1000

Code: U076Q6Q621

Class Code: IACT

CROSPOVIDONE, UNSPECIFIED

Code: 2S7830E561

Class Code: IACT

Active Moieties

Code: 2BTY8KH53L

Deferiprone

Basic Information

Regulatory Information

Company Information

Active Ingredients

METHYLCELLULOSE (15 MPA.S)

POLYSORBATE 80

HYPROMELLOSE, UNSPECIFIED

MAGNESIUM STEARATE

TITANIUM DIOXIDE

POLYETHYLENE GLYCOL 1000

CROSPOVIDONE, UNSPECIFIED

Active Moieties

DEFERIPRONE