United States· US:50458-028_72f41f05-3dfc-48be-b824-90a2090e9b25
Spravato
A medicinal product containing esketamine hydrochloride, registered in United States by Janssen Pharmaceuticals 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
- ESKETAMINE HYDROCHLORIDE
- Manufacturer
- Janssen Pharmaceuticals Inc.
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- August 23, 2026
Packs & prices · 2
- ndc1150458-028-02
- ndc1150458-028-03
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Esketamine hydrochloride in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandEsketamine KalceksAS Kalceks
- NetherlandsEsketamine 5 mg/ml Focus, oplossing voor injectie / infusieFocus Care Pharmaceuticals B.V.
- GermanyEsketaminInresa Arzneimittel Gmbh
- United KingdomEsketamine 250mg/10ml solution for injection ampoulesSintetica Ltd
- SwedenEsketamine Kalceks 25 mg/ml Injektions-/infusionsvätska, lösningAS KALCEKS
- BelgiumEsketamine Kalceks 25 mg/mlKalceks
- SwitzerlandEsketamin Sintetica 25 mg/ml, soluzione iniettabile o per infusioneSintetica SA
- CzechiaSPRAVATOJanssen-Cilag International N.V., Beerse
Authorised across Europe · EMA
The same active substance is authorised in 17 EEA countries. Names it is sold under:
- Austria · Escetex, Eskelan
- Belgium · Esketamine Kalceks, Vesierra
- Germany · Esketamin, Esketamin Inresa
- Denmark · Esketamine Orifarm, S-Ketamin Pfizer
- Estonia · Esketex
- Finland · Esketamine Kalceks, Esketamine Orifarm
- France · Eskesia, Esketamine Renaudin
- United Kingdom (Northern Ireland) · Esketamine Idd, Esketamine Kalceks
- Croatia · Esgamda
- Iceland · S-Ketamin Pfizer, Spravato
- Liechtenstein · Spravato
- Luxembourg · Vesierra
- Latvia · Esketamine Kalceks
- Netherlands · Esketamine Focus, Esketamine Idd
- Norway · Ketanest, Sinmelan
- Sweden · Esketamine Kalceks, Esketamine Orifarm
- Slovenia · Esketamin Kalceks, Sinmelan
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/db141fa5-71e3-4896-9f29-92521725a806 GET /v1/drugs/db141fa5-71e3-4896-9f29-92521725a806?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": "NASAL",
"source": "ndc",
"strength": "28",
"substance": "ESKETAMINE HYDROCHLORIDE",
"productndc": "50458-028",
"dosage_form": "SOLUTION",
"dea_schedule": "CIII",
"strength_unit": "mg/.2mL",
"application_number": "NDA211243",
"marketing_category": "NDA"
}See everything about esketamine hydrochloride.
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.