68727-100 : Xyrem .5 g/ml Oral Solution

NDC:	68727-100
Labeler:	Jazz Pharmaceuticals, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Xyrem
Dosage Form:	Oral Solution
Application #:	NDA021196
Rev. Date:	Jul 17, 2002
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:

• 68727-100-01: 1 BOTTLE, PLASTIC IN 1 CARTON (68727‑100‑01) > 180 ML IN 1 BOTTLE, PLASTIC

Active Ingredients:

• Sodium 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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