Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC] - N0000194006

Pharmacologic Code	N0000194006
Pharmacologic Name	Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator
Pharmacologic Uses	neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator
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 4 products whose active ingredient are classified under the same pharmacologic class Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC].

	NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Status
	64406-029	Zurzuvae	Non-Proprietary Name: Zuranolone	Capsule	Oral	Biogen Ma Inc.	ACTIVE
	64406-030	Zurzuvae	Non-Proprietary Name: Zuranolone	Capsule	Oral	Biogen Ma Inc.	ACTIVE
	64406-031	Zurzuvae	Non-Proprietary Name: Zuranolone	Capsule	Oral	Biogen Ma Inc.	ACTIVE
	81583-100	Ztalmy	Non-Proprietary Name: Ganaxolone	Suspension	Oral	Marinus Pharmaceuticals, Inc.	ACTIVE