Voydeya Tablet, Film Coated
NDC Package 25682-043-92

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

Package Information

Voydeya (danicopan) tablets is vOYDEYA is indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH). This formulation utilizes a tablet, film coated delivery system. Marketed by Alexion Pharmaceuticals Inc., this product is identified by NDC 25682-043 and is authorized under FDA application NDA218037.

Identification & Billing

NDC Package Code
25682-043-92
Package Description
2 BOTTLE in 1 CARTON / 90 TABLET, FILM COATED in 1 BOTTLE
Product Code
25682-043
11-Digit Billing Format
25682004392
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
2 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Voydeya
Non-Proprietary Name
Danicopan
Substance Name
Danicopan
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)
DANICOPAN 100 mg/1
Pharmacologic Class
Usage Information
VOYDEYA is indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH).

Regulatory & Marketing

Labeler Name
Alexion Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA218037
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-29-2024
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 25682-043-92 identifies a specific commercial package of 2 bottle in 1 carton / 90 tablet, film coated in 1 bottle of Voydeya, a human prescription drug labeled by Alexion Pharmaceuticals Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 2 billable units per package. This tablet, film coated is formulated for oral use and contains danicopan 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 Alexion Pharmaceuticals Inc. on March 29, 2024. The current certification is valid through December 31, 2027.

How is this Alexion Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 25682004392. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 2 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)
25682-043-92
11-Digit CMS (5-4-2)
25682-0043-92

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