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  5. NDC Package Code: 50474-992-80 Zilbrysq

NDC Package 50474-992-80 Zilbrysq

Zilucoplan Injection, Solution Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Zilbrysq
Non-Proprietary Name:
Zilucoplan
Substance Name:
Zilucoplan
Usage Information:
ZILBRYSQ is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
11-Digit NDC Billing Format:
50474099280
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to 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]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Ucb, Inc.
    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(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • ZILUCOPLAN 40 mg/mL
    • Pharmacologic Class(es):
  • Complement Inhibitor - [EPC] (Established Pharmacologic Class)
  • Complement Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA216834
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    01-03-2024
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 50474-992-80?

    The NDC Packaged Code 50474-992-80 is assigned to a 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.. The product's dosage form is injection, solution and is administered via subcutaneous form.

    Is NDC 50474-992 included in the NDC Directory?

    Yes, Zilbrysq with product code 50474-992 is active and included in the NDC Directory. The product was first marketed by Ucb, Inc. on January 03, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 50474-992-80?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 50474-992-80?

    The 11-digit format is 50474099280. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-250474-992-805-4-250474-0992-80