sodium oxybate
sodium oxybate is listed in the FDA National Drug Code directory with 16 NDC codes, marketed under brand names including Lumryz, sodium oxybate, Xyrem. Available dosage forms: for suspension, extended release, solution, kit.
Drug Details
- Generic Name
- sodium oxybate
- Brand Names
- Lumryz, sodium oxybate, Xyrem
- Application Number
- NDA214755
- Sponsor
- Avadel CNS Pharmaceuticals, LLC
- NDC Codes
- 16
- Dosage Forms
- FOR SUSPENSION, EXTENDED RELEASE, SOLUTION, KIT
- Routes
- ORAL
- Active Ingredients
- SODIUM OXYBATE
Indications and Usage
1 INDICATIONS AND USAGE LUMRYZ is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. LUMRYZ is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy ( 1 ).