United States· US:82928-300_16d31d7e-dc21-4cdb-92b8-56919827a192
EKTERLY
A sebetralstat product containing sebetralstat, registered in United States by KalVista Pharmaceuticals Ltd. The same ATC class is registered in 9 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Sebetralstat is registered in 9 of 19 countries.
Countries holding a registration under ATC B06AC08 (sebetralstat), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 6 of them publish a price we can compare per daily dose
Sebetralstat · ATC B06AC08
9 / 19 countries
- Belgiumprice
- Czechiaprice
- Finlandprice
- Icelandprice
- Ireland
- Japan
- Netherlands
- Switzerlandprice
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- SEBETRALSTAT
- Manufacturer
- KalVista Pharmaceuticals Ltd
- Country
- United States (US)
- ATC code
- B06AC08
- ATC class
- Sebetralstat
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 3
- ndc1182928-300-04
- ndc1182928-300-05
- ndc1182928300044 BLISTER PACK in 1 CARTON (82928-300-04) / 1 TABLET in 1 BLISTER PACK (82928-300-01)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Sebetralstat in 9 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwitzerlandEkterly 300 mg, FilmtablettenKalVista Pharmaceuticals Switzerland GmbH
- CzechiaEKTERLYKalVista Pharmaceuticals (Ireland) Ltd., Dublin
- IrelandEkterly 300 mg film-coated tabletsKalvista Pharmaceuticals (Ireland) Limited
- IcelandEkterlyKalvista Pharmaceuticals (Ireland) Limited
- NetherlandsEkterly 300 mg filmomhulde tablettenKalvista Pharmaceuticals (Ireland) Limited
- PolandEkterlyKalVista Pharmaceuticals (Ireland) Ltd.
- BelgiumEkterly 300 mgKalvista Pharmaceuticals (Ireland)
- SwedenEkterly 300 mg Filmdragerad tablettKalvista Pharmaceuticals (Ireland) Limited
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Ekterly
- Liechtenstein · Ekterly
- Norway · Ekterly
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/919dbf19-df9a-4447-a689-c57afef2aa46 GET /v1/drugs/919dbf19-df9a-4447-a689-c57afef2aa46?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": "300",
"substance": "SEBETRALSTAT",
"productndc": "82928-300",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA219301",
"marketing_category": "NDA"
}See everything about sebetralstat.
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.