Medicine
Sodium oxybate 0.5 g/mL oral solution
Sodium oxybate 0.5 g/mL oral solution is a generic prescription medicine for oral use, made by 4 labelers, 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
Sodium oxybate oral solution should be stored at 20°C to 25°C (68° to 77°F)…
Key facts
- Active ingredient (INN)
- Sodium oxybate
- Brand
- Sold under the generic name
- Strength
- 0.5 g/mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 1 bottle, 180 mL and 1 more
- Manufacturers
- Camber PharmaceuticalsIndiaAmneal PharmaceuticalsHikma PharmaceuticalsXLCare Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Sodium oxybate oral solution should be stored at 20°C to 25°C (68° to 77°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
- 3 January 2023
- Identifiers
- RxCUI 349482DailyMed set ID 5dcf9a5c-312b-420b-82f3-42177d8f9ee4, c0fb2620-7247-464d-a37a-8b516ce7d563, bcef2c95-35e9-464d-9025-652acff769e7 +1NDC 31722-891, 72865-349, 0054-9628 +1Application ANDA210523, NDA021196, ANDA203631
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 180 mL in 1 bottle | 31722-891-18 | Camber PharmaceuticalsIndia | 1 January 2026 |
| 1 bottle in 1 carton / 180 mL in 1 bottle | 65162-065-87 | Amneal Pharmaceuticals | 12 September 2025 |
| 180 mL in 1 bottle, plastic | 0054-9628-57 | Hikma Pharmaceuticals | 3 January 2023 |
| 1 bottle in 1 carton / 180 mL in 1 bottle | 72865-349-18 | XLCare Pharmaceuticals | 1 January 2026 |
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 Sodium oxybate 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.