United States· US:16110-391_89dd936d-4a69-4c60-b743-dfefb589ec1a

Klisyri

A tirbanibulin product containing tirbanibulin, registered in United States by Almirall, LLC. The same ATC class is registered in 12 of our 19 countries.

ATC D06BX03US label

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

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedKlisyriATCD06BX03REGISTER NO.US:16110-391_89dd936d…PACKS LISTED4CHECKEDAugust 30, 2026

Where it is registered

Tirbanibulin is registered in 12 of 19 countries.

Countries holding a registration under ATC D06BX03 (tirbanibulin), 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

Tirbanibulin · ATC D06BX03

12 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Italyprice
  • Netherlands
  • Polandprice
  • Switzerlandprice
  • United Kingdom
  • 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
TIRBANIBULIN
Manufacturer
Almirall, LLC
Country
United States (US)
ATC code
D06BX03
ATC class
Tirbanibulin
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
August 30, 2026

Packs & prices · 4

  • ndc11
    1611039105
    5 PACKET in 1 CARTON (16110-391-05) / .25 g in 1 PACKET
  • ndc11
    1611039155
    5 PACKET in 1 CARTON (16110-391-55) / .35 g in 1 PACKET
  • ndc11
    16110-391-05
  • ndc11
    16110-391-55

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Tirbanibulin in 12 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All tirbanibulin products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Klisyri
  • Liechtenstein · Klisyri
  • Norway · Klisyri

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/0d9505a7-3bc7-4d2e-8272-0df16a00ea2b
GET /v1/drugs/0d9505a7-3bc7-4d2e-8272-0df16a00ea2b?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": "TOPICAL",
  "source": "ndc",
  "strength": "10",
  "substance": "TIRBANIBULIN",
  "productndc": "16110-391",
  "dosage_form": "OINTMENT",
  "dea_schedule": null,
  "strength_unit": "mg/g",
  "application_number": "NDA213189",
  "marketing_category": "NDA"
}

See everything about tirbanibulin.

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.