United States· US:79378-310_71b050b3-07a6-401f-9526-104383bff7b7
CTEXLI
A medicinal product containing chenodiol, registered in United States by Mirum 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
- CHENODIOL
- Manufacturer
- Mirum 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 · 2
- ndc117937831090100 TABLET, FILM COATED in 1 BOTTLE (79378-310-90)
- ndc1179378-310-90
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Chenodiol in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomChenodeoxycholic acid 200mg tabletsSpecial Order
- BelgiumBelkyra 10 mg/mlAbbvie
- CzechiaCHENODEOXYCHOLIC ACID LEADIANTLeadiant Biosciences Ireland Limited, Dublin
- SpainÁCIDO QUENODESOXICÓLICO LEADIANT 250 MG CÁPSULAS DURASLeadiant Gmbh
- FinlandChenodeoxycholic Acid LeadiantLeadiant Biosciences Ireland Limited
- FranceCHENODEOXYCHOLIC ACID LEADIANT 250 mg, gélulesLEADIANT BIOSCIENCES IRELAND (IRLANDE)
- IrelandChenodeoxycholic acid Leadiant 250 mg hard capsulesLeadiant Biosciences Ireland Limited
- IcelandChenodeoxycholic acid LeadiantLeadiant GmbH
Authorised across Europe · EMA
The same active substance is authorised in 4 EEA countries. Names it is sold under:
- Iceland · Chenodeoxycholic Acid, Chenodeoxycholic Acid Leadiant
- Liechtenstein · Chenodeoxycholic Acid, Chenodeoxycholic Acid Leadiant
- Norway · Chenodeoxycholic Acid, Chenodeoxycholic Acid Leadiant
- Portugal · Xebyl
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/18ba520d-2f0a-4a7b-abe2-ab17a955a023 GET /v1/drugs/18ba520d-2f0a-4a7b-abe2-ab17a955a023?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": "CHENODIOL",
"productndc": "79378-310",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA219488",
"marketing_category": "NDA"
}See everything about chenodiol.
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.