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  5. NDC Package Code: 59922-643-60 Vafseo

NDC Package 59922-643-60 Vafseo

Vadadustat Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
59922-643-60
Package Description:
1 BOTTLE in 1 CARTON / 60 TABLET, FILM COATED in 1 BOTTLE
Product Code:
59922-643
Proprietary Name:
Vafseo
Non-Proprietary Name:
Vadadustat
Substance Name:
Vadadustat
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)].
11-Digit NDC Billing Format:
59922064360
NDC to RxNorm Crosswalk:
  • RxCUI: 2679301 - vadadustat 150 MG Oral Tablet
  • RxCUI: 2679307 - Vafseo 150 MG Oral Tablet
  • RxCUI: 2679307 - vadadustat 150 MG Oral Tablet [Vafseo]
  • RxCUI: 2679309 - vadadustat 300 MG Oral Tablet
  • RxCUI: 2679311 - Vafseo 300 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Akebia Therapeutics, Inc.
    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):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • VADADUSTAT 450 mg/1
    • Sample Package:
    No
    FDA Application Number:
    NDA215192
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-28-2024
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 59922-643-60?

    The NDC Packaged Code 59922-643-60 is assigned to a 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.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 59922-643 included in the NDC Directory?

    Yes, Vafseo with product code 59922-643 is active and included in the NDC Directory. The product was first marketed by Akebia Therapeutics, Inc. on March 28, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 59922-643-60?

    The 11-digit format is 59922064360. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-259922-643-605-4-259922-0643-60