Zilbrysq Injection, Solution
NDC Package 50474-992-80

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

Package Information

Zilbrysq (zilucoplan) injection is zILBRYSQ is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. This formulation utilizes a injection, solution delivery system. Marketed by Ucb, Inc., this product is identified by NDC 50474-992 and is authorized under FDA application NDA216834.

Identification & Billing

NDC Package Code
50474-992-80
Package Description
4 CARTON in 1 BOX / 7 SYRINGE, GLASS in 1 CARTON / .81 mL in 1 SYRINGE, GLASS
Product Code
50474-992
11-Digit Billing Format
50474099280
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2672496 - zilucoplan 16.6 MG in 0.416 ML Prefilled Syringe
  • RxCUI: 2672496 - 0.416 ML zilucoplan 40 MG/ML Prefilled Syringe
  • RxCUI: 2672496 - zilucoplan 16.6 MG (equivalent to zilucoplan sodium 17 MG) per 0.416 ML Prefilled Syringe
  • RxCUI: 2672502 - ZILBRYSQ 16.6 MG in 0.416 ML Prefilled Syringe
  • RxCUI: 2672502 - 0.416 ML zilucoplan 40 MG/ML Prefilled Syringe [Zilbrysq]

Clinical Specifications

Proprietary Name
Zilbrysq
Non-Proprietary Name
Zilucoplan
Substance Name
Zilucoplan
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
ZILUCOPLAN 40 mg/mL
Pharmacologic Class
Usage Information
ZILBRYSQ is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Regulatory & Marketing

Labeler Name
Ucb, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA216834
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-03-2024
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 50474-992-80 identifies a specific commercial package of 4 carton in 1 box / 7 syringe, glass in 1 carton / .81 ml in 1 syringe, glass of Zilbrysq, a human prescription drug labeled by Ucb, Inc.. This injection, solution is formulated for subcutaneous use and contains zilucoplan 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 Ucb, Inc. on January 03, 2024. The current certification is valid through December 31, 2027.

How is this Ucb, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50474099280. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
50474-992-80
11-Digit CMS (5-4-2)
50474-0992-80

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