FERRIPROX

Basic Information

Product Name

FERRIPROX

FDA Product Code

10122-103

Regulatory Information

NDC Product Code

10122-103

Application Number

NDA021825

Marketing Category

C73594

Effective Date

July 27, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use FERRIPROX Tablets safely and effectively. See full prescribing information for FERRIPROX Tablets . FERRIPROX (deferiprone) tablets , for oral use Initial 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

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

METHYLCELLULOSE (15 MPA.S)

Code: NPU9M2E6L8

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

HYPROMELLOSE 2910 (5 MPA.S)

Code: R75537T0T4

Class Code: IACT

CROSPOVIDONE (120 .MU.M)

Code: 68401960MK

Class Code: IACT

POLYETHYLENE GLYCOL 8000

Code: Q662QK8M3B

Class Code: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)

Code: RFW2ET671P

Class Code: IACT

Active Moieties

DEFERIPRONE

Code: 2BTY8KH53L

Basic Information

Regulatory Information

Company Information

Active Ingredients

MAGNESIUM STEARATE

METHYLCELLULOSE (15 MPA.S)

TITANIUM DIOXIDE

HYPROMELLOSE 2910 (5 MPA.S)

CROSPOVIDONE (120 .MU.M)

POLYETHYLENE GLYCOL 8000

HYDROXYPROPYL CELLULOSE (1600000 WAMW)

Active Moieties

DEFERIPRONE