NDC 25682-028 Ultomiris

Ravulizumab Solution, Concentrate Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
25682-028
Proprietary Name:
Ultomiris
Non-Proprietary Name: [1]
Ravulizumab
Substance Name: [2]
Ravulizumab
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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(s): [4]
  • Intravenous - Administration within or into a vein or veins.
  • Labeler Name: [5]
    Alexion Pharmaceuticals Inc.
    Labeler Code:
    25682
    FDA Application Number: [6]
    BLA761108
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    10-09-2020
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 25682-028-01

    Package Description: 1 VIAL, GLASS in 1 CARTON / 11 mL in 1 VIAL, GLASS

    Product Details

    What is NDC 25682-028?

    The NDC code 25682-028 is assigned by the FDA to the product Ultomiris which is a human prescription drug product labeled by Alexion Pharmaceuticals Inc.. The generic name of Ultomiris is ravulizumab. The product's dosage form is solution, concentrate and is administered via intravenous form. The product is distributed in a single package with assigned NDC code 25682-028-01 1 vial, glass in 1 carton / 11 ml in 1 vial, 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 Ultomiris?

    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.

    What are Ultomiris 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.

    What is the NDC to RxNorm Crosswalk for Ultomiris?

    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:

    Which are the Pharmacologic Classes for Ultomiris?

    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.

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    Patient Education

    Ravulizumab-cwvz Injection


    Ravulizumab-cwvz injection is used in adults and children 1 month of age and older to treat paroxysmal nocturnal hemoglobinuria (PNH: a type of anemia in which too many red blood cells are broken down in the body, so there are not enough healthy cells to bring oxygen to all parts of the body). Ravulizumab-cwvz injection is also used in adults and children 1 month of age and older to treat atypical hemolytic uremic syndrome (aHUS; an inherited condition in which small blood clots form in the body and may cause damage to the blood vessels, blood cells, kidneys, and other parts of the body). Ravulizumab-cwvz injection is also used in adults to treat a certain form of myasthenia gravis (MG; a disorder of the nervous system that causes muscle weakness). Ravulizumab-cwvz is in a class of medications called monoclonal antibodies. It works by blocking the activity of the part of the immune system that may damage blood cells in people with PNH and that causes clots to form in people with aHUS. It works by disrupting communication between nerves and muscles in people with 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".