Ultomiris Solution, Concentrate
NDC Package 25682-028-01

11-digit billing NDC: 25682002801
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Ultomiris (ravulizumab) solution is uLTOMIRIS is contraindicated for initiation in patients with unresolved serious Neisseria meningitidis infection [see Warnings and Precautions (5.1)]. This formulation utilizes a solution, concentrate delivery system. Marketed by Alexion Pharmaceuticals Inc., this product is identified by NDC 25682-028 and is authorized under FDA application BLA761108.

Identification & Billing

NDC Package Code
25682-028-01
Package Description
1 VIAL, GLASS in 1 CARTON / 11 mL in 1 VIAL, GLASS
Product Code
25682-028
11-Digit Billing Format
25682002801

Clinical Specifications

Proprietary Name
Ultomiris
Non-Proprietary Name
Ravulizumab
Substance Name
Ravulizumab
Dosage Form
Solution, Concentrate - A liquid preparation (i.e., a substance that flows readily in its natural state) that contains a drug dissolved in a suitable solvent or mixture of mutually miscible solvents; the drug has been strengthened by the evaporation of its nonactive parts.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
RAVULIZUMAB 1100 mg/11mL
Pharmacologic Class
Usage Information
ULTOMIRIS is contraindicated for initiation in patients with unresolved serious Neisseria meningitidis infection [see Warnings and Precautions (5.1)].

Regulatory & Marketing

Labeler Name
Alexion Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761108
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
10-09-2020
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1303
Source: ASP
Inj., ravulizumab-cwvz 10 mg
HCPCS Dosage 10 MG
Units / Pkg 110

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 25682-028-01 identifies a specific commercial package of 1 vial, glass in 1 carton / 11 ml in 1 vial, glass of Ultomiris, a human prescription drug labeled by Alexion Pharmaceuticals Inc.. This solution, concentrate is formulated for intravenous use and contains ravulizumab 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 October 09, 2020. 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: 25682002801. 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)
25682-028-01
11-Digit CMS (5-4-2)
25682-0028-01

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