United States· US:15054-3302_8caf9de8-b831-4bbf-91c1-12a269bee890
Bylvay
A odevixibat product containing odevixibat, registered in United States by Ipsen Biopharmaceuticals, Inc.. The same ATC class is registered in 15 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Odevixibat is registered in 15 of 19 countries.
Countries holding a registration under ATC A05AX05 (odevixibat), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 9 of them publish a price we can compare per daily dose
Odevixibat · ATC A05AX05
15 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Japan
- Netherlands
- Polandprice
- Spainprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- ODEVIXIBAT
- Manufacturer
- Ipsen Biopharmaceuticals, Inc.
- Country
- United States (US)
- ATC code
- A05AX05
- ATC class
- Odevixibat
- Defined daily dose
- 2.4 mg, O
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1115054330211 BOTTLE in 1 CARTON (15054-3302-1) / 30 CAPSULE in 1 BOTTLE
- ndc1115054-3302-1
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Odevixibat in 9 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SpainBYLVAY 400 MICROGRAMOS CAPSULAS DURASIpsen Pharma
- NetherlandsBylvay 400 microgram harde capsulesIpsen Pharma
- PolandBylvayIpsen Pharma
- SwedenBylvay 400 mikrogram Kapsel, hårdIpsen Pharma
- IrelandKAYFANDA 400 microgram hard capsulesIpsen Pharma
- SwitzerlandBylvay 400 μg, HartkapselnIPSEN Pharma Schweiz GmbH
- United KingdomBylvay 400microgram capsulesIpsen Ltd
- CanadaBYLVAYMEDISON PHARMA CANADA INC.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Bylvay, Kayfanda
- Liechtenstein · Bylvay, Kayfanda
- Norway · Bylvay, Kayfanda
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/4e5e350a-09e9-495e-89a9-0b2b0d64a98b GET /v1/drugs/4e5e350a-09e9-495e-89a9-0b2b0d64a98b?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": "400",
"substance": "ODEVIXIBAT",
"productndc": "15054-3302",
"dosage_form": "CAPSULE",
"dea_schedule": null,
"strength_unit": "ug/1",
"application_number": "NDA215498",
"marketing_category": "NDA"
}See everything about odevixibat.
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.