United States· US:70183-125_4d71b74f-8d8b-4701-ba16-08c7c4d8a7f6
Xermelo
A medicinal product containing telotristat ethyl, registered in United States by Lexicon 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
- TELOTRISTAT ETHYL
- Manufacturer
- Lexicon 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
- September 27, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Telotristat ethyl in 4 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CanadaXERMELOSERB SAS
- United KingdomXermelo 250mg tabletsSERB
- NorwayXermeloSERB SAS
- SwedenXermelo 250 mg Filmdragerad tablettSERB SAS
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Xermelo
- Liechtenstein · Xermelo
- Norway · Xermelo
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/e0ae0728-ec14-4a9c-96b0-8026744ad0c9 GET /v1/drugs/e0ae0728-ec14-4a9c-96b0-8026744ad0c9?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": "250",
"substance": "TELOTRISTAT ETHYL",
"productndc": "70183-125",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA208794",
"marketing_category": "NDA"
}See everything about telotristat ethyl.
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.