INFED
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use INFeD safely and effectively. See full prescribing information for INFeD.INFeD® (iron dextran injection), for intravenous or intramuscular useInitial U.S. Approval: 1974
Approved
Approval ID
3cbcd123-0097-4778-98df-09371837c3a6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2022
Manufacturers
FDA
General Injectables & Vaccines, Inc.
DUNS: 108250663
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
iron dextran
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52584-086
Application NumberNDA017441
Product Classification
M
Marketing Category
C73594
G
Generic Name
iron dextran
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateDecember 22, 2022
FDA Product Classification
INGREDIENTS (2)
IRON DEXTRANActive
Quantity: 50 mg in 1 mL
Code: 95HR524N2M
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT