Medicine
Tolvaptan 30 mg tablet
Tolvaptan 30 mg tablet is a generic prescription medicine for oral use, made by 7 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
Store at 20°C to 25°C (68°F to 77°F), excursions permitted from 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Tolvaptan
- Brand
- Sold under the generic name
- Strength
- 30 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 10 tablets, 1 blister pack and 11 more
- Manufacturers
- Ascend LaboratoriesIndiaCamber PharmaceuticalsIndiaLupinIndiaNovadoz PharmaceuticalsIndiaApotexNorthStar RxPar Health
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted from 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
- 21 May 2020
- Identifiers
- RxCUI 849827, 849833, 2044363 +7DailyMed set ID d9fd11d0-4269-12fb-95cf-b3c11d75e479, dd71ee70-9435-4715-bee5-edbb5a8d7d7b, 5b14ba2b-9f80-41d6-9613-f16d3cf37d25 +6NDC 60505-4318, 67877-636, 49884-770 +6Application ANDA207605, ANDA211891, ANDA206119 +5
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 |
|---|---|---|---|
| 100 tablet in 1 bottle | 67877-636-01 | Ascend LaboratoriesIndia | 21 May 2020 |
| 10 tablet in 1 bottle | 67877-636-02 | Ascend LaboratoriesIndia | 21 May 2020 |
| 1 blister pack in 1 carton / 10 tablet in 1 blister pack | 67877-636-33 | Ascend LaboratoriesIndia | 21 May 2020 |
| 30 tablet in 1 bottle | 67877-916-30 | Ascend LaboratoriesIndia | 1 September 2026 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 31722-869-01 | Camber PharmaceuticalsIndia | 16 July 2021 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 31722-869-02 | Camber PharmaceuticalsIndia | 16 July 2021 |
| 1 blister pack in 1 carton / 10 tablet in 1 blister pack | 31722-869-03 | Camber PharmaceuticalsIndia | 16 July 2021 |
| 1 blister pack in 1 carton / 10 tablet in 1 blister pack | 31722-869-04 | Camber PharmaceuticalsIndia | 16 July 2021 |
| 30 tablet in 1 bottle | 70748-239-06 | LupinIndia | 12 May 2025 |
| 1 blister pack in 1 carton / 10 tablet in 1 blister pack | 72205-131-11 | Novadoz PharmaceuticalsIndia | 26 September 2023 |
| 1 blister pack in 1 carton / 10 tablet in 1 blister pack | 60505-4318-0 | Apotex | 5 July 2022 |
| 30 tablet in 1 bottle | 60505-4782-3 | Apotex | 6 August 2026 |
| 1 blister pack in 1 carton / 10 tablet in 1 blister pack | 49884-770-54 | Par Health | 10 March 2022 |
| 1 blister pack in 1 carton / 10 tablet in 1 blister pack | 72603-933-01 | Northstar Rx | 1 July 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 Tolvaptan 30 mg tablet.
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 30 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.