Deferiprone
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
Approved
Approval ID
c4f9e9be-39e7-4940-9cb0-f17772d7e524
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 080189610
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 Code0054-0711
Application NumberANDA213239
Product Classification
M
Marketing Category
C73584
G
Generic Name
Deferiprone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2023
FDA Product Classification
INGREDIENTS (8)
DEFERIPRONEActive
Quantity: 1000 mg in 1 1
Code: 2BTY8KH53L
Classification: ACTIB
METHYLCELLULOSE (15 MPA.S)Inactive
Code: NPU9M2E6L8
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 1000Inactive
Code: U076Q6Q621
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT