United States· US:69238-1640_08b2264e-d081-4558-9893-0a11d25e7a39
Pirfenidone
A pirfenidone product containing pirfenidone, registered in United States by Amneal Pharmaceuticals NY LLC. The same ATC class is registered in 17 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Pirfenidone is registered in 17 of 19 countries.
Countries holding a registration under ATC L04AX05 (pirfenidone), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 9 of them publish a price we can compare per daily dose
Pirfenidone · ATC L04AX05
17 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Germany
- Icelandprice
- Ireland
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Sweden
- Switzerlandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of pirfenidone costs, country by country.
Normalised to the WHO defined daily dose (2.4 g), the median price runs from $27.36 in France to $63.67 in Switzerland — a ×2.3 gap.
- 2 markets with a comparable price for this class
- Public list prices, converted to USD at the rate date shown
Pirfenidone · price per daily dose (2.4 g)
USD · FX 28 Sept 2026
- CH Switzerland$63.67
- FR France$27.36
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- PIRFENIDONE
- Manufacturer
- Amneal Pharmaceuticals NY LLC
- Country
- United States (US)
- ATC code
- L04AX05
- ATC class
- Pirfenidone
- Defined daily dose
- 2.4 g, O
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1169238164083 BOTTLE, PLASTIC in 1 CARTON (69238-1640-8) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69238-1640-9)
- ndc1169238-1640-8
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
132 interactions on record for pirfenidone.
Graded by severity as the source publishes them — 20 severe. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Pirfenidone · interactions on record
132 records
- 20 severe
- 110 moderate
- 2 minor
Most severe, free to view
- GivosiranA16AX16severe
- AmiodaroneC01BD01severe
- MipomersenC10AX11severe
- LomitapideC10AX12severe
- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Same medicine, other countries
Pirfenidone in 17 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaESBRIETH.A.C. Pharma, Caen
- SpainESBRIET 267 MG COMPRIMIDOS RECUBIERTOS CON PELICULAH.A.C. Pharma
- SwedenEsbriet 267 mg Filmdragerad tablettH.A.C. Pharma
- NetherlandsEsbriet 267 mg, filmomhulde tabletH.A.C. Pharma
- IrelandEsbriet 267 mg film-coated tabletsRoche Registration Limited
- FinlandEsbrietH.A.C. Pharma
- PolandEsbrietRoche Registration GmbH
- BelgiumEsbriet 267 mgH.A.C. Pharma
Authorised across Europe · EMA
The same active substance is authorised in 31 EEA countries. Names it is sold under:
- Austria · Pirfenidon Accord, Pirfenidon Actavis
- Belgium · Perfenidon Eg, Pirfenidon Cipla
- Bulgaria · Fredalix
- Cyprus · Pirfenidone Accord, Pirfenidone Msn
- Czechia · Fredalix, Pirfenidon Zentiva
- Germany · Equitor, Pirfenair
- Denmark · Fredalix, Pirfenair
- Estonia · Pirfenidone Accord, Pirfenidone Msn
- Spain · Pirfenidona Accord, Pirfenidona Aurovitas
- Finland · Pirfenidon Cipla, Pirfenidone Accord
- France · Pirfenidon Eg Labo - Laboratoireseurogenerics, Pirfenidone Accord
- United Kingdom (Northern Ireland) · Pirfenidon Msn Laboratories Europe, Pirfenidone
- Greece · Orepir, Pirfenidone Accord
- Croatia · Pirfenidon Accord, Pirfenidon Sandoz
- Hungary · Pirfenidon Zentiva
- Ireland · Pirfenidone Accord, Pirfenidone Axunio
- Iceland · Esbriet, Pirfenidon Medical Valley
- Italy · Blamonehel, Pirfenidone Accord
- Liechtenstein · Esbriet, Pirfenidone Viatris
- Lithuania · Pirfenidone Accord, Pirfenidone Msn
- Luxembourg · Pirfenidon Eg
- Latvia · Pirfenidone Accord, Pirfenidone Msn
- Malta · Pirfenidone Clonmel, Pirfenidone Msn
- Netherlands · Pirfenidon Accord, Pirfenidon Amarox
- Norway · Esbriet, Pirfenidon Cipla
- Poland · Pirfenidon Cipla Europe, Pirfenidon Medical Valley
- Portugal · Pirfenidona Accord, Pirfenidona Generis
- Romania · Pirfenidon Msn
- Sweden · Pirfenidon Cipla, Pirfenidon Medical Valley
- Slovenia · Pirfenidon Accord, Pirfenidon Teva
- Slovakia · Pirfenidón Accord, Pirfenidone Msn
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/f597e04e-87cf-4454-a8dd-59ee29272dc8 GET /v1/drugs/f597e04e-87cf-4454-a8dd-59ee29272dc8?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": "267",
"substance": "PIRFENIDONE",
"productndc": "69238-1640",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA212570",
"marketing_category": "ANDA"
}See everything about pirfenidone.
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.