Medicine
Jynarque kit
Jynarque kit is a prescription medicine containing Tolvaptan, marketed by Otsuka America Pharmaceutical, 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
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and…
Key facts
- Active ingredient (INN)
- Tolvaptan
- Brand
- Jynarque
- Dosage form
- Kit
- Packs
- 4 blister pack and 2 more
- Marketing authorisation holder
- Otsuka America Pharmaceutical
- Manufacturer
- Otsuka America Pharmaceutical
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C03XA01 Tolvaptan
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 April 2018
- Identifiers
- RxCUI 2044355, 2044357, 2044359 +7DailyMed set ID 3febc0a1-9e5a-4ce0-843d-210f21d862c4NDC 59148-088, 59148-089, 59148-079 +2Application NDA204441
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 |
|---|---|---|---|
| 4 blister pack in 1 carton / 1 kit in 1 blister pack | 59148-079-28 | Otsuka America Pharmaceutical | 13 January 2020 |
| 4 blister pack in 1 carton / 1 kit in 1 blister pack | 59148-080-28 | Otsuka America Pharmaceutical | 13 January 2020 |
| 4 blister pack in 1 carton / 1 kit in 1 blister pack | 59148-087-28 | Otsuka America Pharmaceutical | 23 April 2018 |
| 4 blister pack in 1 carton / 1 kit in 1 blister pack | 59148-088-28 | Otsuka America Pharmaceutical | 23 April 2018 |
| 4 blister pack in 1 carton / 1 kit in 1 blister pack | 59148-089-28 | Otsuka America Pharmaceutical | 23 April 2018 |
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
Other strengths and forms of Tolvaptan
Clinical summary
Tolvaptan is a vasopressin V2 receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction). MedsAcross supplies Tolvaptan 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 TolvaptanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- SAMSCA prescribing information (Otsuka America Pharmaceutical) · U.S. National Library of Medicine, DailyMed
- Jinarc: European public assessment report (EPAR) · European Medicines Agency
- Samsca: European public assessment report (EPAR) · European Medicines Agency
Need Jynarque kit 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.