Histamine-3 Receptor Antagonist/Inverse Agonist [EPC] - N0000194053

Pharmacologic Code	N0000194053
Pharmacologic Name	Histamine-3 Receptor Antagonist/Inverse Agonist
Pharmacologic Uses	histamine-3 (H3) receptor antagonist/inverse agonist
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 2 products whose active ingredient are classified under the same pharmacologic class Histamine-3 Receptor Antagonist/Inverse Agonist [EPC].

	NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Status
	72028-045	Wakix	Non-Proprietary Name: Pitolisant Hydrochloride	Tablet, Film Coated	Oral	Harmony Biosciences, Llc	ACTIVE
	72028-178	Wakix	Non-Proprietary Name: Pitolisant Hydrochloride	Tablet, Film Coated	Oral	Harmony Biosciences, Llc	ACTIVE