68727-150 : Xywav Oral Solution

NDC:	68727-150
Labeler:	Jazz Pharmaceuticals, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Xywav
Dosage Form:	Oral Solution
Application #:	NDA212690
Rev. Date:	Nov 2, 2020
CSA Schedule:	CIII (US) [1]

^[1] Schedule III / IIIN Controlled Substance: Has a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. (i.e. Products containing not more than 90 milligrams of Codeine per dosage unit [such as Tylenol with Codeine], other narcotics such as Buprenorphine (Suboxone), and Schedule IIIN non-narcotics such as Didrex, Ketamine, Phendimetrazine, and Anabolic Steroids). More Details: US Dept of Justice Controlled Substance Schedules.

NDC Package Codes:

• 68727-150-01: 180 ML IN 1 BOTTLE, PLASTIC (68727‑150‑01)

Active Ingredients:

• Sodium Oxybate
• Calcium Oxybate
• Potassium Oxybate
• Magnesium Oxybate

Pharmaceutical Classes:

• Central Nervous System Depressant [EPC]
• Central Nervous System Depression [PE]
• Decreased Central Nervous System Organized Electrical Activity [PE]

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