Glycolipid Disialoganglioside-directed Antibody [EPC] - N0000191500

Name: Table of NDC products with glycolipid disialoganglioside-directed antibody
Creator: U.S. Food & Drug Administration
License: https://creativecommons.org/licenses/by-nc-sa/4.0/

Pharmacologic Class Information

Pharmacologic Code	N0000191500
Pharmacologic Name	Glycolipid Disialoganglioside-directed Antibody
Pharmacologic Uses	GD2-binding monoclonal antibody
Pharmacologic Concept	Established Pharmacologic Classes - [EPC]
Pharmacologic Concept Description	An established pharmacologic class is a term or phrase that is scientifically valid and clinically meaningful according to the following definitions: A scientifically valid pharmacologic class is supported by documented and submitted empiric evidence showing that the drug's pharmacologic class is known, not theoretical, and relevant and specific to the indication. A clinically meaningful pharmacologic class term or phrase enhances the ability of professionals to understand physiologic effects related to the indication or to anticipate undesirable effects that may be associated with the drug or pharmacologic class.

NDC Products with Glycolipid Disialoganglioside-directed Antibody

The table contains 2 products whose active ingredient are classified under the same pharmacologic class Glycolipid Disialoganglioside-directed Antibody [EPC].

	NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Status
	66302-014	Unituxin	Non-Proprietary Name: Dinutuximab	Injection	Intravenous	United Therapeutics Corporation	ACTIVE
	73042-201	Danyelza	Non-Proprietary Name: Naxitamab	Injection	Intravenous	Y-mabs Therapeutics, Inc.	ACTIVE