NDC 59922-631 Auryxia

Ferric Citrate Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
59922-631
Proprietary Name:
Auryxia
Non-Proprietary Name: [1]
Ferric Citrate
Substance Name: [2]
Tetraferric Tricitrate Decahydrate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Akebia Therapeutics, Inc.
    Labeler Code:
    59922
    FDA Application Number: [6]
    NDA205874
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    09-17-2014
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    PINK (C48328)
    Shape:
    OVAL (C48345)
    Size(s):
    19 MM
    Imprint(s):
    KX52
    Score:
    1

    Product Packages

    NDC Code 59922-631-01

    Package Description: 200 TABLET, FILM COATED in 1 BOTTLE

    Price per Unit: $7.23105 per EA

    Product Details

    What is NDC 59922-631?

    The NDC code 59922-631 is assigned by the FDA to the product Auryxia which is a human prescription drug product labeled by Akebia Therapeutics, Inc.. The generic name of Auryxia is ferric citrate. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in a single package with assigned NDC code 59922-631-01 200 tablet, film coated in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Auryxia?

    Ferric citrate is used to lower high blood phosphate levels in people who are on dialysis due to severe kidney disease. Dialysis removes some phosphate from your blood, but it is difficult to remove enough to keep your phosphate levels balanced. Decreasing blood phosphate levels can help keep your bones strong, prevent unsafe buildup of minerals in your body, and may decrease the risk of heart disease and strokes that can result from high phosphate levels. This medication works by binding to phosphate in the foods you eat. The phosphate then passes out of your body in your stool. Ferric citrate is a form of iron. This medication is also used to treat low blood levels of iron (anemia) in people with long-term kidney disease who are not on dialysis. Iron is an important mineral that your body needs to produce red blood cells and keep you in good health.

    What are Auryxia Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Auryxia UNII Codes?

    The UNII codes for the active ingredients in this product are:

    • TETRAFERRIC TRICITRATE DECAHYDRATE (UNII: Q91187K011)
    • FERRIC CATION (UNII: 91O4LML611) (Active Moiety)

    What is the NDC to RxNorm Crosswalk for Auryxia?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

    Which are the Pharmacologic Classes for Auryxia?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Ferric Citrate


    Ferric citrate is used to control high blood levels of phosphorus in people with chronic kidney disease who are on dialysis (medical treatment to clean the blood when the kidneys are not working properly). Ferric citrate is also used to treat iron-deficiency anemia (a lower than normal number of red blood cells due to too little iron) in adults with chronic kidney disease (damage to the kidneys which may worsen over time and may cause the kidneys to stop working) who are not on dialysis. Ferric citrate is in a class of medications called phosphate binders and iron replacement products. It works to control high blood levels of phosphorus by binding phosphorus that you get from foods in your diet and prevents it from being absorbed into your blood stream. It works to treat iron-deficiency anemia by replenishing iron stores so that the body can make more red blood cells.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".