United States· US:57894-080_da4a9239-16d7-46cf-b089-e943e0080015
LAZCLUZE
A lazertinib product containing lazertinib, registered in United States by Janssen Biotech, 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
Lazertinib is registered in 13 of 19 countries.
Countries holding a registration under ATC L01EB09 (lazertinib), 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
Lazertinib · ATC L01EB09
13 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of lazertinib costs, country by country.
Normalised to the WHO defined daily dose (0.24 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
Lazertinib · price per daily dose (0.24 g)
USD · FX 28 Sept 2026
- CH Switzerland$339.05
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- LAZERTINIB
- Manufacturer
- Janssen Biotech, Inc.
- Country
- United States (US)
- ATC code
- L01EB09
- ATC class
- Lazertinib
- Defined daily dose
- 0.24 g, O
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 4
- ndc1157894080601 BOTTLE in 1 CARTON (57894-080-60) / 60 TABLET, FILM COATED in 1 BOTTLE
- ndc1157894080901 BOTTLE in 1 CARTON (57894-080-90) / 90 TABLET, FILM COATED in 1 BOTTLE
- ndc1157894-080-60
- ndc1157894-080-90
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Lazertinib in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaLAZCLUZEJanssen-Cilag International N.V., Beerse
- NorwayLazcluzeJanssen-Cilag International N.V.
- SpainLAZCLUZE 80 MG COMPRIMIDOS RECUBIERTOS CON PELICULAJanssen-Cilag International N.V
- FinlandLazcluzeJanssen Cilag International
- IrelandLazcluze 80 mg film-coated tabletsJanssen-Cilag International NV
- IcelandLazcluzeJanssen-Cilag International NV*
- NetherlandsLazcluze 80 mg filmomhulde tablettenJanssen-Cilag International NV
- PolandLazcluzeJanssen-Cilag International N.V.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Lazcluze
- Liechtenstein · Lazcluze
- Norway · Lazcluze
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/69c65277-279b-4a32-838b-172d5821ed31 GET /v1/drugs/69c65277-279b-4a32-838b-172d5821ed31?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": "80",
"substance": "LAZERTINIB",
"productndc": "57894-080",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA219008",
"marketing_category": "NDA"
}See everything about lazertinib.
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.