Ferumoxytol
These highlights do not include all the information needed to use FERUMOXYTOL INJECTION safely and effectively. See full prescribing information for FERUMOXYTOL INJECTION. FERUMOXYTOL injection, for intravenous use Initial U.S. Approval: 2009
Approved
Approval ID
cf94c7fc-13a0-4ac9-bb85-9c38aa704d35
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 27, 2022
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
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 Code0781-3154
Application NumberANDA206604
Product Classification
M
Marketing Category
C73584
G
Generic Name
ferumoxytol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 22, 2020
FDA Product Classification
INGREDIENTS (2)
MANNITOLInactive
Quantity: 748 mg in 17 mL
Code: 3OWL53L36A
Classification: IACT
FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITEActive
Quantity: 510 mg in 17 mL
Code: CLH5FT6412
Classification: ACTIB