Medicine
Tolvaptan 45 mg tablet
Tolvaptan 45 mg tablet is a generic prescription medicine for oral use, 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 to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Tolvaptan
- Brand
- Sold under the generic name
- Strength
- 45 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets
- Manufacturer
- Ascend LaboratoriesIndia
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 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)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 September 2026
- Identifiers
- RxCUI 2044359, 2044363, 2044367 +7DailyMed set ID 82ef58ef-ce46-434e-bf99-89fce51094f1NDC 67877-917Application ANDA220147
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 |
|---|---|---|---|
| 30 tablet in 1 bottle | 67877-917-30 | Ascend LaboratoriesIndia | 1 September 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
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 Tolvaptan 45 mg tablet 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.