Auryxia
These highlights do not include all the information needed to use AURYXIA safely and effectively. See full prescribing information for AURYXIA. AURYXIA (ferric citrate) tablets, for oral use Initial U.S. Approval: 2014
Approved
Approval ID
aadd18e0-3752-11e4-8510-0800200c9a66
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 22, 2024
Manufacturers
FDA
Akebia Therapeutics, Inc.
DUNS: 809557593
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ferric citrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59922-631
Application NumberNDA205874
Product Classification
M
Marketing Category
C73594
G
Generic Name
ferric citrate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 18, 2021
FDA Product Classification
INGREDIENTS (1)
TETRAFERRIC TRICITRATE DECAHYDRATEActive
Quantity: 210 mg in 1 1
Code: Q91187K011
Classification: ACTIM
