Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC] - N0000175822

Name: Table of NDC products with hydrolytic lysosomal neutral glycosphingolipid-specific enzyme
Creator: U.S. Food & Drug Administration
License: https://creativecommons.org/licenses/by-nc-sa/4.0/

Pharmacologic Class Information

Pharmacologic Code	N0000175822
Pharmacologic Name	Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme
Pharmacologic Uses	hydrolytic lysozomal neutral glycosphingolipid-specific enzyme
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 Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme

The table contains 2 products whose active ingredient are classified under the same pharmacologic class Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC].

	NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Status
	58468-0040	Fabrazyme	Non-Proprietary Name: Agalsidase Beta	Injection, Powder, Lyophilized, For Solution	Intravenous	Genzyme Corporation	ACTIVE
	58468-0041	Fabrazyme	Non-Proprietary Name: Agalsidase Beta	Injection, Powder, Lyophilized, For Solution	Intravenous	Genzyme Corporation	ACTIVE