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NDC 25682-0031-01 ULTOMIRIS Details

ULTOMIRIS

ULTOMIRIS is a KIT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Alexion Pharmaceuticals Inc.. The primary component is .

MedlinePlus Drug Summary

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.

Related Packages: 25682-0031-01
Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Ravulizumab-cwvz Injection

Product Information

NDC	25682-0031
Product ID	25682-031_c8439051-24bd-414a-8bd7-26d307991212
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	ULTOMIRIS
Proprietary Name Suffix	n/a
Non-Proprietary Name	RAVULIZUMAB
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	KIT
Route	n/a
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	Alexion Pharmaceuticals Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	BLA
Application Number	BLA761108
Listing Certified Through	2024-12-31

Package

NDC 25682-0031-01 (25682003101)

Pricing Information	N/A
NDC Package Code	25682-031-01
Billing NDC	25682003101
Package	1 KIT in 1 CARTON (25682-031-01) * 1 CARTRIDGE in 1 TRAY / 3.5 mL in 1 CARTRIDGE
Marketing Start Date	2023-04-01
NDC Exclude Flag	N