68727-150 : Xywav Oral Solution


NDC68727-150
Labeler: Jazz Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Xywav
Dosage Form: Oral Solution
Application #: NDA212690
Rev. Date: 
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

Dosage Strength:

  • .5 g/mL
  • .5 g/mL
  • .5 g/mL
  • .5 g/mL

Pharmaceutical Classes:

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

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