United States· US:60505-4317_f0a587b3-af44-097a-8e8a-8cfd15676e33
tolvaptan
A medicinal product containing tolvaptan, registered in United States by Apotex Corp..
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- TOLVAPTAN
- Manufacturer
- Apotex Corp.
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1160505-4317-0
- ndc1160505-4317-3
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Tolvaptan in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SpainJINARC 15 mg + 45 mg COMPRIMIDOSOtsuka Pharmaceutical Netherlands B.V.
- IcelandGurdatolSandoz A/S
- SwedenJinarc 15 mg TablettOtsuka Pharmaceutical Netherlands B.V.
- CzechiaJINARCOtsuka Pharmaceutical Netherlands B.V., Amsterdam
- NorwayJinarcOtsuka Pharmaceutical Netherlands B.V.
- FranceJINARC 15 mg, compriméOTSUKA PHARMACEUTICAL NETHERLANDS (PAYS BAS)
- United KingdomJinarc 15mg tabletsOtsuka Pharmaceuticals (U.K.) Ltd
- NetherlandsJinarc 15 mg, tabletOtsuka Pharmaceutical Netherlands B.V.
Authorised across Europe · EMA
The same active substance is authorised in 21 EEA countries. Names it is sold under:
- Austria · Tolvaptan, Tolvaptan +pharma
- Belgium · Tolvaptan, Tolvaptan Eg
- Czechia · Tolvaptan Stada
- Germany · Tolvaptan, Tolvaptan 1 A Pharma
- Estonia · Tolvaptan Stada
- Spain · Tolvaptán Sandoz, Tolvaptan Stadafarma
- France · Tolvaptan Biogaran, Tolvaptan Eg
- United Kingdom (Northern Ireland) · Tolvaptan, Tolvaptan Genus Pharmaceuticals
- Greece · Gurdatol, Pokydy
- Croatia · Gurdatol
- Ireland · Tolvaptan Ascend
- Iceland · Gurdatol, Jinarc
- Italy · Tolvaptan Teva, Tolvaptan Teva Italia
- Liechtenstein · Jinarc, Samsca
- Lithuania · Tolvaptan Stada
- Latvia · Tolvaptan Stada
- Netherlands · Tolvaptan Sandoz, Tolvaptan Teva
- Norway · Jinarc, Samsca
- Poland · Tolvaptan Sandoz
- Portugal · Tolvaptano Stada, Tolvaptano Stada 15 Mg + 45 Mg Comprimidos
- Sweden · Tolvaptan Hexal, Tolvaptan Sandoz
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/036c52cd-d643-4d0f-8e68-bd4afc125505 GET /v1/drugs/036c52cd-d643-4d0f-8e68-bd4afc125505?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "ORAL",
"source": "ndc",
"strength": "15",
"substance": "TOLVAPTAN",
"productndc": "60505-4317",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA207605",
"marketing_category": "ANDA"
}See everything about tolvaptan.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.