NDC 25682-028 Ultomiris
Ravulizumab Solution, Concentrate Intravenous - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 25682 - Alexion Pharmaceuticals Inc.
- 25682-028 - Ultomiris
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?
What are the uses for Ultomiris?
What are Ultomiris Active Ingredients?
What is the NDC to RxNorm Crosswalk for Ultomiris?
- RxCUI: 2107320 - ravulizumab-cwvz 300 MG in 30 ML Injection
- RxCUI: 2107320 - 30 ML ravulizumab-cwvz 10 MG/ML Injection
- RxCUI: 2107320 - ravulizumab-cwvz 300 MG per 30 ML Injection
- RxCUI: 2107325 - ULTOMIRIS 300 MG in 30 ML Injection
- RxCUI: 2107325 - 30 ML ravulizumab-cwvz 10 MG/ML Injection [Ultomiris]
Which are the Pharmacologic Classes for Ultomiris?
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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.
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[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".