United States· US:65597-801_c5c6cd04-1bea-4809-a830-b1fb1ba94e97
DATROWAY
A datopotamab deruxtecan product containing datopotamab deruxtecan, registered in United States by Daiichi Sankyo Inc.. The same ATC class is registered in 9 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Datopotamab deruxtecan is registered in 9 of 19 countries.
Countries holding a registration under ATC L01FX35 (datopotamab deruxtecan), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 6 of them publish a price we can compare per daily dose
Datopotamab deruxtecan · ATC L01FX35
9 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Switzerlandprice
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- DATOPOTAMAB DERUXTECAN
- Manufacturer
- Daiichi Sankyo Inc.
- Country
- United States (US)
- ATC code
- L01FX35
- ATC class
- Datopotamab deruxtecan
- Defined daily dose
- 20 mg, P
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1165597-801-01
- ndc1165597801011 VIAL, SINGLE-DOSE in 1 CARTON (65597-801-01) / 5 mL in 1 VIAL, SINGLE-DOSE
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Datopotamab deruxtecan in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumDatroway 100 mgDaiichi Sankyo Europe
- SwitzerlandDATROWAY 100 mg, Pulver für ein Konzentrat zur Herstellung einer InfusionslösungDaiichi Sankyo (Schweiz) AG
- CzechiaDATROWAYDaiichi Sankyo Europe GmbH, Mnichov
- SpainDATROWAY 100 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSIONDaiichi Sankyo Europe Gmbh
- FinlandDatrowayDaiichi Sankyo Europe GmbH
- IrelandDatroway 100 mg powder for concentrate for solution for infusionDaiichi Sankyo Europe GmbH
- IcelandDatrowayDAIICHI SANKYO EUROPE GmbH*
- Japanダトポタマブ デルクステカン（遺伝子組換え）第一三共
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Datroway
- Liechtenstein · Datroway
- Norway · Datroway
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/8d539305-87cd-45dc-b3db-cc08634cf2a2 GET /v1/drugs/8d539305-87cd-45dc-b3db-cc08634cf2a2?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": "100",
"substance": "DATOPOTAMAB DERUXTECAN",
"productndc": "65597-801",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"dea_schedule": null,
"strength_unit": "mg/5mL",
"application_number": "BLA761394",
"marketing_category": "BLA"
}See everything about datopotamab deruxtecan.
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.