Feraheme
These highlights do not include all the information needed to use Feraheme safely and effectively. See full prescribing information for Feraheme. Feraheme® (ferumoxytol injection), for intravenous use Initial U.S. Approval: 2009
Approved
Approval ID
32b0e320-a739-11dc-a704-0002a5d5c51b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 13, 2022
Manufacturers
FDA
AMAG Pharmaceuticals, Inc.
DUNS: 017511155
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ferumoxytol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59338-775
Application NumberNDA022180
Product Classification
M
Marketing Category
C73594
G
Generic Name
ferumoxytol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 13, 2022
FDA Product Classification
INGREDIENTS (2)
FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITEActive
Quantity: 510 mg in 17 mL
Code: CLH5FT6412
Classification: ACTIB
MANNITOLInactive
Quantity: 748 mg in 17 mL
Code: 3OWL53L36A
Classification: IACT