Source: FDA, National Drug Code (US) Revision Year: 2020
Sodium oxybate, a CNS depressant, is the active ingredient in Xyrem. The chemical name for sodium oxybate is sodium 4-hydroxybutyrate. The molecular formula is C4H7NaO3, and the molecular weight is 126.09 g/mole.
The chemical structure is:
Sodium oxybate is a white to off-white, crystalline powder that is very soluble in aqueous solutions. Each mL of Xyrem contains 0.5 g of sodium oxybate (equivalent to 0.413 g/mL of oxybate) in USP Purified Water, neutralized to pH 7.5 with malic acid.
| Dosage Forms and Strengths |
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Xyrem is a clear to slightly opalescent oral solution, in a concentration of 0.5 g per mL (0.5 g/mL of sodium oxybate equivalent to 0.413 g/mL of oxybate). |
| How Supplied |
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Xyrem is a clear to slightly opalescent oral solution. Each prescription includes one bottle of Xyrem with attached press in bottle adaptor, an oral measuring device (plastic syringe), and a Medication Guide. The pharmacy provides two empty containers with child-resistant caps with each Xyrem shipment. Each amber bottle contains Xyrem oral solution at a concentration of 0.5 g per mL (0.5 g/mL of sodium oxybate equivalent to 0.413 g/mL of oxybate) and has a child-resistant cap. One 180 mL bottle NDC 68727-100-01 Distributed By: Jazz Pharmaceuticals, Inc., Palo Alto, CA 94304 |
| Drug | Countries | |
|---|---|---|
| XYREM | Austria, Canada, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Turkey, United Kingdom, United States |
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