Auryxia Tablet, Film Coated
NDC Package 59922-631-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Auryxia (ferric citrate) tablets is ferric citrate is used to lower high blood phosphate levels in people who are on dialysis due to severe kidney disease. This formulation utilizes a tablet, film coated delivery system. Marketed by Akebia Therapeutics, Inc., this product is identified by NDC 59922-631 and is authorized under FDA application NDA205874.

Identification & Billing

NDC Package Code
59922-631-01
Package Description
200 TABLET, FILM COATED in 1 BOTTLE
Product Code
59922-631
11-Digit Billing Format
59922063101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
200 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Auryxia
Non-Proprietary Name
Ferric Citrate
Substance Name
Tetraferric Tricitrate Decahydrate
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TETRAFERRIC TRICITRATE DECAHYDRATE 210 mg/1
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Akebia Therapeutics, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA205874
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-17-2014
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 59922-631-01 identifies a specific commercial package of 200 tablet, film coated in 1 bottle of Auryxia, a human prescription drug labeled by Akebia Therapeutics, Inc.. This tablet, film coated is formulated for oral use and contains tetraferric tricitrate decahydrate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Akebia Therapeutics, Inc. on September 17, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Akebia Therapeutics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59922063101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 200 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
59922-631-01
11-Digit CMS (5-4-2)
59922-0631-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.