United States· US:80610-430_e16c73c6-8f2a-470b-9504-83b183e9df16
ZORYVE
A roflumilast product containing roflumilast, registered in United States by Arcutis Biotherapeutics, Inc.. The same ATC class is registered in 2 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Roflumilast is registered in 2 of 19 countries.
Countries holding a registration under ATC D05AX06 (roflumilast), 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
Roflumilast · ATC D05AX06
2 / 19 countries
- Canada
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- ROFLUMILAST
- Manufacturer
- Arcutis Biotherapeutics, Inc.
- Country
- United States (US)
- ATC code
- D05AX06
- ATC class
- Roflumilast
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- June 26, 2026
Packs & prices · 2
- ndc1180610430601 CAN in 1 CARTON (80610-430-60) / 60 g in 1 CAN
- ndc1180610-430-60
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Roflumilast in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaDAXASAstraZeneca AB, Södertälje
- GermanyRoflum HexalHexal Ag
- SwedenDaxas 250 mikrogram TablettAstraZeneca AB
- United KingdomDaxas 250microgram tabletsAstraZeneca UK Ltd
- SpainDAXAS 250 MICROGRAMOS COMPRIMIDOSAstrazeneca Ab
- FinlandDalirespAstraZeneca AB
- BelgiumDaliresp 500 µgAstraZeneca
- CanadaDAXASASTRAZENECA CANADA INC
Authorised across Europe · EMA
The same active substance is authorised in 15 EEA countries. Names it is sold under:
- Austria · Rofluma, Roflumilast Accord
- Cyprus · Damirast
- Czechia · Rumixafen
- Germany · Roflum Hexal, Roflumila Puren
- Denmark · Firekol
- Spain · Roflumilast Aurovitas
- Finland · Firekol
- United Kingdom (Northern Ireland) · Roflumilast Milpharm, Roflumilast Torrent Pharma (Uk)
- Greece · Damirast
- Iceland · Daxas
- Liechtenstein · Daxas
- Norway · Daxas, Firekol
- Portugal · Roflumilaste Generis
- Sweden · Firekol, Roflumilast Accord
- Slovakia · Rumixafen
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/cd7626b7-7721-466b-8276-eaed472764a6 GET /v1/drugs/cd7626b7-7721-466b-8276-eaed472764a6?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": "3",
"substance": "ROFLUMILAST",
"productndc": "80610-430",
"dosage_form": "AEROSOL, FOAM",
"dea_schedule": null,
"strength_unit": "mg/g",
"application_number": "NDA217242",
"marketing_category": "NDA"
}See everything about roflumilast.
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.