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  4. NDC Product Code: 50474-990 Zilbrysq

NDC 50474-990 Zilbrysq

Zilucoplan Injection, Solution Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 50474-990?
  4. Zilbrysq Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

NDC Product Code:
50474-990
Proprietary Name:
Zilbrysq
Non-Proprietary Name: [1]
Zilucoplan
Substance Name: [2]
Zilucoplan
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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): [4]
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Labeler Name: [5]
    Ucb, Inc.
    Labeler Code:
    50474
    Product Label ID:
    9f1d53d6-e495-4a3a-8bb9-680a15d25034
    FDA Application Number: [6]
    NDA216834
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    01-03-2024
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 50474-990?

    The NDC code 50474-990 is assigned by the FDA to the product Zilbrysq which is a human prescription drug product labeled by Ucb, Inc.. The generic name of Zilbrysq is zilucoplan. The product's dosage form is injection, solution and is administered via subcutaneous form. The product is distributed in a single package with assigned NDC code 50474-990-80 4 carton in 1 box / 7 syringe, glass in 1 carton / .416 ml in 1 syringe, glass. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Zilbrysq?

    ZILBRYSQ is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

    What are Zilbrysq Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Zilbrysq UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Zilbrysq Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Zilbrysq?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • 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]

    Which are the Pharmacologic Classes for Zilbrysq?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Zilucoplan Injection


    Zilucoplan injection is used to treat myasthenia gravis (MG; a disorder of the nervous system that causes muscle weakness) in certain adult patients. Zilucoplan is in a class of medications called compliment inhibitors. It works by stopping the compliment system from damaging the acetylcholine receptors on the muscles, which is what causes the symptoms of MG.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".