Medicine
Xyrem 0.5 g/mL oral solution
Xyrem 0.5 g/mL oral solution is a prescription medicine containing Sodium oxybate for oral use, marketed by Jazz Pharmaceuticals, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Xyrem should be stored at 25°C (77°F), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Sodium oxybate
- Brand
- Xyrem
- Strength
- 0.5 g/mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 180 mL
- Marketing authorisation holder
- Jazz Pharmaceuticals
- Manufacturer
- Jazz Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Xyrem should be stored at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Storage Keep out of reach of children.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIII
- ATC code
- N01AX11 Sodium oxybate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 17 July 2002
- Identifiers
- RxCUI 349482, 352257DailyMed set ID 926eb076-a4a8-45e4-91ef-411f0aa4f3caNDC 68727-100Application NDA021196
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 180 mL in 1 bottle, plastic | 68727-100-01 | Jazz Pharmaceuticals | 17 July 2002 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Sodium oxybate 0.5 g/mL oral solution.
Other strengths and forms of Sodium oxybate
Clinical summary
Sodium oxybate 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. MedsAcross supplies Sodium oxybate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Sodium oxybateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Xyrem prescribing information (Jazz Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Xyrem: European public assessment report (EPAR) · European Medicines Agency
Need Xyrem 0.5 g/mL oral solution for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.