Medicine
Xywav 0.5 g/0.5 g/0.5 g/0.5 g per mL oral solution
Xywav 0.5 g/0.5 g/0.5 g/0.5 g per mL oral solution is a prescription medicine containing Calcium oxybate, Magnesium oxybate, Potassium oxybate and 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
XYWAV should be stored between 20°C to 25°C (68°F to 77°F), excursions…
Key facts
- Active ingredient (INN)
- Calcium oxybate, Magnesium oxybate, Potassium oxybate and Sodium oxybate
- Brand
- Xywav
- Strength
- 0.5 g/0.5 g/0.5 g/0.5 g per 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
- XYWAV should be stored between 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Storage Keep out of reach of children.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIII
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 2 November 2020
- Identifiers
- RxCUI 2393794, 2393795DailyMed set ID 1e0ae43a-037f-42af-8e23-a0e51d75abe8NDC 68727-150Application NDA212690
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 | 68727-150-01 | Jazz Pharmaceuticals | 2 November 2020 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 21 July 2020 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
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
Clinical summary
Calcium oxybate, Magnesium oxybate, Potassium oxybate and Sodium oxybate is a fixed-dose combination medicine. It is available as oral solution. MedsAcross supplies Calcium oxybate, Magnesium oxybate, Potassium oxybate and 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 Calcium oxybate, Magnesium oxybate, Potassium oxybate and 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
- XYWAV prescribing information (Jazz Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Xywav 0.5 g/0.5 g/0.5 g/0.5 g per 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.