Medicine
Esbriet 801 mg tablet
Esbriet 801 mg tablet is a prescription medicine containing Pirfenidone for oral use, marketed by Legacy Pharma, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 25°C (77°F), excursions permitted to 15–30°C (59–86°F).
Key facts
- Active ingredient (INN)
- Pirfenidone
- Brand
- Esbriet
- Strength
- 801 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Legacy Pharma
- Manufacturers
- Legacy PharmaGenentech
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15–30°C (59–86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AX05 Pirfenidone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 11 January 2017
- Identifiers
- RxCUI 1868014, 1868016, 1868018 +3DailyMed set ID 81f17f7d-cb04-4052-8682-dd3e330210ab, 2e8c3537-36d7-4de5-9b5c-7a624b9a9e6eNDC 83107-029, 50242-123Application NDA208780
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle, plastic in 1 carton / 90 tablet, coated in 1 bottle, plastic | 83107-029-90 | Legacy Pharma | 4 June 2025 |
| 1 bottle, plastic in 1 carton / 90 tablet, coated in 1 bottle, plastic | 50242-123-01 | Genentech | 11 January 2017 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Pirfenidone 801 mg tablet.
Other strengths and forms of Pirfenidone
Clinical summary
Pirfenidone is a pyridone indicated for the treatment of idiopathic pulmonary fibrosis (IPF). It is available as tablets and capsules for oral use. MedsAcross supplies Pirfenidone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about PirfenidoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ESBRIET prescribing information (Genentech) · U.S. National Library of Medicine, DailyMed
- Esbriet: European public assessment report (EPAR) · European Medicines Agency
- Pirfenidone axunio (previously Pirfenidone AET): European public assessment report (EPAR) · European Medicines Agency
Need Esbriet 801 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.