Drug Database
Back to search

United States· US:15054-0050_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.

ATC M09AX11

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedSOHONOSATCM09AX11REGISTER NO.US:15054-0050_9175478…PACKS LISTED1CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about palovaroteneAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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
Search palovarotene products by name

Palovarotene · ATC M09AX11

3 / 19 countries

  • Canada
  • Japan
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

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

  • ndc11
    15054-0050-1

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.

All palovarotene products

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/d388a7df-2a67-4f64-be3f-ff644625b812
GET /v1/drugs/d388a7df-2a67-4f64-be3f-ff644625b812?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": "5",
  "substance": "PALOVAROTENE",
  "productndc": "15054-0050",
  "dosage_form": "CAPSULE",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "NDA215559",
  "marketing_category": "NDA"
}
API referenceMCP serverPlans

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.

Try it freeOpen in the console