United States· US:59148-083_3be8a6fe-a8d0-43ca-a84d-183b522a3cf4
JYNARQUE
A medicinal product containing tolvaptan, registered in United States by Otsuka America Pharmaceutical, Inc..
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
- Otsuka America Pharmaceutical, Inc.
- 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
- ndc1159148-083-13
- ndc1159148083131 BOTTLE in 1 CARTON (59148-083-13) / 30 TABLET in 1 BOTTLE
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 30 mg + 60 mg comprimidosOtsuka Pharmaceutical Netherlands B.V.
- SwedenJinarc 30 mg TablettOtsuka Pharmaceutical Netherlands B.V.
- IcelandGurdatolSandoz A/S
- FranceJINARC 30 mg, compriméOTSUKA PHARMACEUTICAL NETHERLANDS (PAYS BAS)
- CzechiaJINARCOtsuka Pharmaceutical Netherlands B.V., Amsterdam
- United KingdomJinarc 30mg tabletsOtsuka Pharmaceuticals (U.K.) Ltd
- NorwayJinarcOtsuka Pharmaceutical Netherlands B.V.
- NetherlandsJinarc 30 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/d262a569-7f1b-406d-a35b-5f683dc7f82a GET /v1/drugs/d262a569-7f1b-406d-a35b-5f683dc7f82a?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": "30",
"substance": "TOLVAPTAN",
"productndc": "59148-083",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA204441",
"marketing_category": "NDA"
}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.