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
NDC Product Code0054-0711
Application NumberANDA213239
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 1, 2023
Generic NameDeferiprone
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