United States· US:0003-4160_03987a7d-5ac9-4c41-9a48-c9aee4dd13de
Augtyro
A repotrectinib product containing repotrectinib, registered in United States by E.R. Squibb & Sons, L.L.C.. The same ATC class is registered in 10 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Repotrectinib is registered in 10 of 19 countries.
Countries holding a registration under ATC L01EX28 (repotrectinib), 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
Repotrectinib · ATC L01EX28
10 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Japan
- Netherlands
- Norwayprice
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- REPOTRECTINIB
- Manufacturer
- E.R. Squibb & Sons, L.L.C.
- Country
- United States (US)
- ATC code
- L01EX28
- ATC class
- Repotrectinib
- Defined daily dose
- 0.32 g, O
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- August 9, 2026
Packs & prices · 4
- ndc11000341601414 CAPSULE in 1 BOTTLE (0003-4160-14)
- ndc11000341606060 CAPSULE in 1 BOTTLE (0003-4160-60)
- ndc110003-4160-14
- ndc110003-4160-60
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Repotrectinib in 9 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaAUGTYROBristol-Myers Squibb Pharma EEIG, Dublin
- FinlandAUGTYROBristol-Myers Squibb Pharma EEIG
- IrelandAUGTYRO 160 mg hard capsulesBristol-Myers Squibb Pharma EEIG
- IcelandAugtyroBristol-Myers Squibb Pharma EEIG
- NetherlandsAUGTYRO 160 mg harde capsulesBristol-Myers Squibb Pharma EEIG
- NorwayAugtyroBristol-Myers Squibb Pharma EEIG
- PolandAugtyroBristol-Myers Squibb Pharma EEIG
- SwedenAugtyro 160 mg Kapsel, hårdBristol-Myers Squibb Pharma EEIG
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Augtyro
- Liechtenstein · Augtyro
- Norway · Augtyro
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/f7119a4c-869a-477e-8b8a-20cc74a4e13c GET /v1/drugs/f7119a4c-869a-477e-8b8a-20cc74a4e13c?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": "160",
"substance": "REPOTRECTINIB",
"productndc": "0003-4160",
"dosage_form": "CAPSULE",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA218213",
"marketing_category": "NDA"
}See everything about repotrectinib.
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.