Vafseo Tablet, Film Coated
NDC Package 59922-643-60

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

Package Information

Vafseo (vadadustat) tablets is vAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.Limitations of UseVAFSEO has not been shown to improve quality of life, fatigue, or patient well-being.VAFSEO is not indicated for use: As a substitute for red blood cell transfusions in patients who require immediate correction of anemiaIn patients with anemia due to CKD not on dialysis [see Warnings and Precautions (5.6)]. This formulation utilizes a tablet, film coated delivery system. Marketed by Akebia Therapeutics, Inc., this product is identified by NDC 59922-643 and is authorized under FDA application NDA215192.

Identification & Billing

NDC Package Code
59922-643-60
Package Description
1 BOTTLE in 1 CARTON / 60 TABLET, FILM COATED in 1 BOTTLE
Product Code
59922-643
11-Digit Billing Format
59922064360
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Vafseo
Non-Proprietary Name
Vadadustat
Substance Name
Vadadustat
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)
VADADUSTAT 450 mg/1
Pharmacologic Class
Usage Information
VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.Limitations of UseVAFSEO has not been shown to improve quality of life, fatigue, or patient well-being.VAFSEO is not indicated for use: As a substitute for red blood cell transfusions in patients who require immediate correction of anemiaIn patients with anemia due to CKD not on dialysis [see Warnings and Precautions (5.6)].

Regulatory & Marketing

Labeler Name
Akebia Therapeutics, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA215192
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-28-2024
Listing Expiration
12-31-2027
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 59922-643-60 identifies a specific commercial package of 1 bottle in 1 carton / 60 tablet, film coated in 1 bottle of Vafseo, a human prescription drug labeled by Akebia Therapeutics, Inc.. This tablet, film coated is formulated for oral use and contains vadadustat 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 March 28, 2024. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59922064360. 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)
59922-643-60
11-Digit CMS (5-4-2)
59922-0643-60

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