Glucosylceramide Synthase Inhibitor [EPC] - N0000175783

Pharmacologic Code	N0000175783
Pharmacologic Name	Glucosylceramide Synthase Inhibitor
Pharmacologic Uses	glucosylceramide synthase inhibitor
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.

The table contains 6 products whose active ingredient are classified under the same pharmacologic class Glucosylceramide Synthase Inhibitor [EPC].

	NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Status
	10148-201	Miglustat	Non-Proprietary Name: Miglustat	Capsule	Oral	Cotherix, Inc.	ACTIVE
	42799-709	Yargesa	Non-Proprietary Name: Miglustat	Capsule	Oral	Edenbridge Pharmaceuticals Llc.	ACTIVE
	43975-310	Miglustat	Non-Proprietary Name: Miglustat	Capsule	Oral	Ani Pharmaceuticals, Inc.	ACTIVE
	58468-0220	Cerdelga	Non-Proprietary Name: Eliglustat	Capsule	Oral	Genzyme Corporation	ACTIVE
	66215-201	Zavesca	Non-Proprietary Name: Miglustat	Capsule	Oral	Actelion Pharmaceuticals Us, Inc.	ACTIVE
	71904-300	Opfolda	Non-Proprietary Name: Miglustat	Capsule	Oral	Amicus Therapeutics Us, Llc	ACTIVE