Central Nervous System Depressant [EPC] - N0000175758

Pharmacologic Code	N0000175758
Pharmacologic Name	Central Nervous System Depressant
Pharmacologic Uses	central nervous system depressant
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 11 products whose active ingredient are classified under the same pharmacologic class Central Nervous System Depressant [EPC].

	NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Status
	0054-9628	Sodium Oxybate	Non-Proprietary Name: Sodium Oxybate	Solution	Oral	Hikma Pharmaceuticals Usa Inc.	ACTIVE
	13551-001	Lumryz	Non-Proprietary Name: Sodium Oxybate	For Suspension, Extended Release	Oral	Avadel Cns Pharmaceuticals, Llc	ACTIVE
	13551-002	Lumryz	Non-Proprietary Name: Sodium Oxybate	For Suspension, Extended Release	Oral	Avadel Cns Pharmaceuticals, Llc	ACTIVE
	13551-003	Lumryz	Non-Proprietary Name: Sodium Oxybate	For Suspension, Extended Release	Oral	Avadel Cns Pharmaceuticals, Llc	ACTIVE
	13551-004	Lumryz	Non-Proprietary Name: Sodium Oxybate	For Suspension, Extended Release	Oral	Avadel Cns Pharmaceuticals, Llc	ACTIVE
	31722-891	Sodium Oxybate	Non-Proprietary Name: Sodium Oxybate	Solution	Oral	Camber Pharmaceuticals, Inc.	ACTIVE
	65162-065	Sodium Oxybate	Non-Proprietary Name: Sodium Oxybate	Solution	Oral	Amneal Pharmaceuticals Llc	ACTIVE
	68727-100	Xyrem	Non-Proprietary Name: Sodium Oxybate	Solution	Oral	Jazz Pharmaceuticals, Inc.	ACTIVE
	68727-150	Xywav	Non-Proprietary Name: Calcium, Magnesium, Potassium, And Sodium Oxybates	Solution	Oral	Jazz Pharmaceuticals, Inc.	ACTIVE
	72865-349	Sodium Oxybate	Non-Proprietary Name: Sodium Oxybate	Solution	Oral	Xlcare Pharmaceuticals, Inc.	ACTIVE