FERRIPROX
These highlights do not include all the information needed to use FERRIPROX safely and effectively. See full prescribing information for FERRIPROX. FERRIPROX (deferiprone) tablets, for oral useInitial U.S. Approval: 2011
Approved
Approval ID
57bd50e6-c948-0037-4a4b-c8951f70d04a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 4, 2020
Manufacturers
FDA
ApoPharma USA, Inc.
DUNS: 962810821
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
deferiprone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52609-0007
Application NumberNDA021825
Product Classification
M
Marketing Category
C73594
G
Generic Name
deferiprone
Product Specifications
Route of AdministrationORAL
Effective DateApril 27, 2011
FDA Product Classification
INGREDIENTS (8)
Methylcellulose (15 Mpa.S)Inactive
Code: NPU9M2E6L8
Classification: IACT
CrospovidoneInactive
Code: 68401960MK
Classification: IACT
DEFERIPRONEActive
Quantity: 1000 mg in 1 1
Code: 2BTY8KH53L
Classification: ACTIB
Hypromellose 2910 (5 Mpa.S)Inactive
Code: R75537T0T4
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Polyethylene Glycol 8000Inactive
Code: Q662QK8M3B
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Drug Labeling Information
BOXED WARNING SECTION
LOINC: 34066-1Updated: 5/31/2017
WARNING: AGRANULOCYTOSIS AND NEUTROPENIA
RECENT MAJOR CHANGES SECTION
LOINC: 43683-2Updated: 3/4/2020
RECENT MAJOR CHANGES
Dosage and Administration, Recommended Dosage (2.1) 08/2019