United States· US:0310-0095_11cd495f-c5cf-4076-b69c-af202ec2a8a1
Daliresp
A roflumilast product containing roflumilast, registered in United States by AstraZeneca Pharmaceuticals LP. 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
Roflumilast is registered in 3 of 19 countries.
Countries holding a registration under ATC Roflumilast (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 Roflumilast
3 / 19 countries
- Germany
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- ROFLUMILAST
- Manufacturer
- AstraZeneca Pharmaceuticals LP
- Country
- United States (US)
- ATC code
- Roflumilast
- ATC class
- Roflumilast
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 4
- ndc11031000953030 TABLET in 1 BOTTLE, PLASTIC (0310-0095-30)
- ndc11031000959090 TABLET in 1 BOTTLE, PLASTIC (0310-0095-90)
- ndc110310-0095-30
- ndc110310-0095-90
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.
- United KingdomDaxas 500microgram tabletsAstraZeneca UK Ltd
- SpainROFLUMILAST AUROVITAS 500 MICROGRAMOS COMPRIMIDOS EFGAurovitas Spain, S.A.U.
- CanadaDAXASASTRAZENECA CANADA INC
- CzechiaDAXASAstraZeneca AB, Södertälje
- GermanyRoflum HexalHexal Ag
- SwedenDaxas 250 mikrogram TablettAstraZeneca AB
- FinlandDalirespAstraZeneca AB
- BelgiumDaliresp 500 µgAstraZeneca
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/cd652d51-d23a-4ef6-a193-d9dd5cfdb155 GET /v1/drugs/cd652d51-d23a-4ef6-a193-d9dd5cfdb155?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": "500",
"substance": "ROFLUMILAST",
"productndc": "0310-0095",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "ug/1",
"application_number": "NDA022522",
"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.