United States· US:15054-0015_91754786-5967-4f1a-90fc-e070366bf0f1
SOHONOS
A palovarotene product containing palovarotene, registered in United States by Ipsen Biopharmaceuticals, Inc.. The same ATC class is registered in 3 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Palovarotene is registered in 3 of 19 countries.
Countries holding a registration under ATC M09AX11 (palovarotene), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 1 of them publish a price we can compare per daily dose
Palovarotene · ATC M09AX11
3 / 19 countries
- Canada
- Japan
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- PALOVAROTENE
- Manufacturer
- Ipsen Biopharmaceuticals, Inc.
- Country
- United States (US)
- ATC code
- M09AX11
- ATC class
- Palovarotene
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 1
- ndc1115054-0015-1
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Palovarotene in 1 other country
What each register calls a product with the same active substance — salts and hydrates count as the same.
Authorised across Europe · EMA
The same active substance is authorised in 1 EEA country. Names it is sold under:
- France · Sohonos
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/54c48cd2-2927-4a7d-9185-63b471601ff8 GET /v1/drugs/54c48cd2-2927-4a7d-9185-63b471601ff8?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": "1.5",
"substance": "PALOVAROTENE",
"productndc": "15054-0015",
"dosage_form": "CAPSULE",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA215559",
"marketing_category": "NDA"
}See everything about palovarotene.
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.