United States· US:0469-4425_869b812d-b22d-49ed-9d86-c30e4a014a9d
VYLOY
A zolbetuximab product containing zolbetuximab, registered in United States by Astellas Pharma US, Inc.. The same ATC class is registered in 13 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Zolbetuximab is registered in 13 of 19 countries.
Countries holding a registration under ATC L01FX31 (zolbetuximab), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 8 of them publish a price we can compare per daily dose
Zolbetuximab · ATC L01FX31
13 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- ZOLBETUXIMAB
- Manufacturer
- Astellas Pharma US, Inc.
- Country
- United States (US)
- ATC code
- L01FX31
- ATC class
- Zolbetuximab
- Defined daily dose
- 51.4 mg, P
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 1
- ndc110469-4425-30
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Zolbetuximab in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwitzerlandVyloy 100 mg, Pulver für ein Konzentrat zur Herstellung einer InfusionslösungAstellas Pharma AG
- CzechiaVYLOYAstellas Pharma Europe B.V., Leiden
- FranceVYLOY 100 mg, poudre pour solution à diluer pour perfusionASTELLAS PHARMA EUROPE (PAYS-BAS)
- United KingdomVyloy 100mg powder for concentrate for solution for infusion vialsAstellas Pharma Ltd
- BelgiumVyloy 100 mgAstellas Pharma Europe
- SpainVYLOY 100 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSIONAstellas Pharma Europe B.V.
- FinlandVyloyAstellas Pharma Europe B.V.
- Japanゾルベツキシマブ（遺伝子組換え）アステラス製薬
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Vyloy
- Liechtenstein · Vyloy
- Norway · Vyloy
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/fca1365b-9645-4e34-96fa-b7c0d95f88c8 GET /v1/drugs/fca1365b-9645-4e34-96fa-b7c0d95f88c8?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": "INTRAVENOUS",
"source": "ndc",
"strength": "20",
"substance": "ZOLBETUXIMAB",
"productndc": "0469-4425",
"dosage_form": "INJECTION, POWDER, FOR SUSPENSION",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "BLA761365",
"marketing_category": "BLA"
}See everything about zolbetuximab.
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.