Velphoro
These highlights do not include all the information needed to use VELPHORO safely and effectively. See full prescribing information for VELPHORO . VELPHORO (sucroferric oxyhydroxide) chewable tablet for oral use Initial U.S. Approval: 2013
Approved
Approval ID
237da26c-f38c-4faa-93ad-735e71c9d0c1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2023
Manufacturers
FDA
Fresenius Medical Care North America
DUNS: 958291411
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sucroferric oxyhydroxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49230-645
Application NumberNDA205109
Product Classification
M
Marketing Category
C73594
G
Generic Name
sucroferric oxyhydroxide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 18, 2023
FDA Product Classification
INGREDIENTS (1)
FERRIC OXYHYDROXIDEActive
Quantity: 500 mg in 1 1
Code: 87PZU03K0K
Classification: ACTIR