Welireg Tablet, Film Coated
NDC Package 0006-5331-01

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

Package Information

Welireg (belzutifan) tablets is wELIREG is indicated for treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. This formulation utilizes a tablet, film coated delivery system. Marketed by Merck Sharp & Dohme Llc, this product is identified by NDC 0006-5331 and is authorized under FDA application NDA215383.

Identification & Billing

NDC Package Code
0006-5331-01
Package Description
90 TABLET, FILM COATED in 1 BOTTLE
Product Code
0006-5331
11-Digit Billing Format
00006533101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Welireg
Non-Proprietary Name
Belzutifan
Substance Name
Belzutifan
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)
BELZUTIFAN 40 mg/1
Pharmacologic Class
Usage Information
WELIREG is indicated for treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.

Regulatory & Marketing

Labeler Name
Merck Sharp & Dohme Llc
Product Type
Human Prescription Drug
FDA Application #
NDA215383
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-13-2021
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0006-5331). Click a package code to view its specific billing and regulatory data.

0006-5331-58
1 BOTTLE in 1 CARTON / 90 TABLET, FILM COATED in 1 BOTTLE
0006-5331-59
1 BOTTLE in 1 CARTON / 90 TABLET, FILM COATED in 1 BOTTLE

* 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 0006-5331-01 identifies a specific commercial package of 90 tablet, film coated in 1 bottle of Welireg, a human prescription drug labeled by Merck Sharp & Dohme Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 90 billable units per package. This tablet, film coated is formulated for oral use and contains belzutifan 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 Merck Sharp & Dohme Llc on August 13, 2021. The current certification is valid through December 31, 2026.

How is this Merck Sharp & Dohme Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00006533101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 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 (4-4-2)
0006-5331-01
11-Digit CMS (5-4-2)
00006-5331-01

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