United States· US:0469-1425_b1aef238-5cd9-47cb-a83f-1f5eac49f013
Xospata
A gilteritinib product containing gilteritinib fumarate, 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
Gilteritinib is registered in 13 of 19 countries.
Countries holding a registration under ATC L01EX13 (gilteritinib), 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
Gilteritinib · ATC L01EX13
13 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of gilteritinib costs, country by country.
Normalised to the WHO defined daily dose (0.12 g), so markets compare like for like.
- 1 market with a comparable price for this class
- Public list prices, converted to USD at the rate date shown
Gilteritinib · price per daily dose (0.12 g)
USD · FX 28 Sept 2026
- CH Switzerland$662.17
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- GILTERITINIB FUMARATE
- Manufacturer
- Astellas Pharma US, Inc.
- Country
- United States (US)
- ATC code
- L01EX13
- ATC class
- Gilteritinib
- Defined daily dose
- 0.12 g, O
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 13, 2026
Packs & prices · 4
- ndc1104691425211 BOTTLE in 1 CARTON (0469-1425-21) / 21 TABLET in 1 BOTTLE
- ndc1104691425901 BOTTLE in 1 CARTON (0469-1425-90) / 90 TABLET in 1 BOTTLE
- ndc110469-1425-21
- ndc110469-1425-90
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
529 interactions on record for gilteritinib.
Graded by severity as the source publishes them — 116 severe. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Gilteritinib · interactions on record
529 records
- 116 severe
- 408 moderate
- 5 minor
Most severe, free to view
- PapaverineA03AD01severe
- CisaprideA03FA02severe
- DolasetronA04AA04severe
- LonafarnibA16AX20severe
- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Same medicine, other countries
Gilteritinib in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomGilteritinib 40mg tabletsAstellas Pharma Ltd
- CanadaXOSPATAASTELLAS PHARMA CANADA INC
- SwitzerlandXospata 40 mg, FilmtablettenAstellas Pharma AG
- CzechiaXOSPATAAstellas Pharma Europe B.V., Leiden
- SpainXOSPATA 40 MG COMPRIMIDOS RECUBIERTOS CON PELICULAAstellas Pharma Europe B.V.
- FinlandXospataAstellas Pharma Europe B.V.
- FranceXOSPATA 40 mg, comprimé pelliculéASTELLAS PHARMA EUROPE (PAYS-BAS)
- IrelandXospata 40 mg film-coated tabletsAstellas Pharma Europe B.V.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Xospata
- Liechtenstein · Xospata
- Norway · Xospata
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/33fa7eac-d32f-4713-ae13-6520872e1194 GET /v1/drugs/33fa7eac-d32f-4713-ae13-6520872e1194?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": "40",
"substance": "GILTERITINIB FUMARATE",
"productndc": "0469-1425",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA211349",
"marketing_category": "NDA"
}See everything about gilteritinib.
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.