IRON DEXTRAN
INFED(R) (IRON DEXTRAN INJECTION, USP) 100mg elemental iron/2mL (50mg/mL) 2mL VIAL
Approved
Approval ID
9a4cd424-865d-fdd1-e053-2995a90a00ff
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 22, 2020
Manufacturers
FDA
HF Acquisition Co LLC, DBA HealthFirst
DUNS: 045657305
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 Code51662-1441
Application NumberNDA017441
Product Classification
M
Marketing Category
C73594
G
Generic Name
IRON DEXTRAN
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateFebruary 22, 2020
FDA Product Classification
INGREDIENTS (2)
IRON DEXTRANActive
Quantity: 50 mg in 1 mL
Code: 95HR524N2M
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT