Ultomiris
NDC Package 25682-031-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Ultomiris is ravulizumab-cwvz is used to treat a certain blood disorder (paroxysmal nocturnal hemoglobinuria). Marketed by Alexion Pharmaceuticals Inc., this product is identified by NDC 25682-031 and is authorized under FDA application BLA761108.

Identification & Billing

NDC Package Code
25682-031-01
Package Description
1 KIT in 1 CARTON * 1 CARTRIDGE in 1 TRAY / 3.5 mL in 1 CARTRIDGE
Product Code
25682-031
11-Digit Billing Format
25682003101

Clinical Specifications

Proprietary Name
Ultomiris
Dosage Form
-
Usage Information
Ravulizumab-cwvz is used to treat a certain blood disorder (paroxysmal nocturnal hemoglobinuria). This disorder causes your body's immune system to destroy red blood cells, which results in anemia. It works by helping block your body's destruction of red blood cells. This effect helps lessen symptoms of anemia (such as tiredness, shortness of breath), and may reduce the need for blood transfusions. This medication may also be used to treat a certain immune system disorder (atypical Hemolytic Uremic Syndrome). It helps to prevent blood clots caused by this disorder. Ravulizumab-cwvz belongs to a class of medications known as monoclonal antibodies.

Regulatory & Marketing

Labeler Name
Alexion Pharmaceuticals Inc.
FDA Application #
BLA761108
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
04-01-2023
End Marketing Date
07-09-2024
Listing Expiration
07-09-2024
Exclude Flag
D
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 25682-031-01 identifies a specific commercial package of 1 kit in 1 carton * 1 cartridge in 1 tray / 3.5 ml in 1 cartridge of Ultomiris, labeled by Alexion Pharmaceuticals Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Alexion Pharmaceuticals Inc. on April 01, 2023. The current certification is valid through July 09, 2024.

What are the primary indications for this medication?

Ravulizumab-cwvz is used to treat a certain blood disorder (paroxysmal nocturnal hemoglobinuria). This disorder causes your body's immune system to destroy red blood cells, which results in anemia. It works by helping block your body's destruction of red blood cells. This effect helps lessen symptoms of anemia (such as tiredness, shortness of breath), and may reduce the need for blood transfusions. This medication may also be used to treat a certain immune system disorder (atypical Hemolytic Uremic Syndrome). It helps to prevent blood clots caused by this disorder. Ravulizumab-cwvz belongs to a class of medications known as monoclonal antibodies.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 25682003101. 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)
25682-031-01
11-Digit CMS (5-4-2)
25682-0031-01

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