Medicine
Pirfenidone 801 mg tablet
Pirfenidone 801 mg tablet is a generic prescription medicine for oral use, made by 21 labelers, 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 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C…
Key facts
- Active ingredient (INN)
- Pirfenidone
- Brand
- Sold under the generic name
- Strength
- 801 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 500 tablets, 90 tablets, 1 bottle and 27 more
- Manufacturers
- Alembic PharmaceuticalsIndiaCiplaIndiaNovadoz PharmaceuticalsIndiaAccord HealthcareIndiaAurobindo PharmaIndiaCamber PharmaceuticalsIndiaLaurus LabsIndiaMicro LabsIndiaAmneal Pharmaceuticals NYBryant Ranch Prepack
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 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
- 29 March 2022
- Identifiers
- RxCUI 1868014, 1868018, 1592279 +2DailyMed set ID a235768d-d26d-4ded-ae75-53e93310ff6a, 1927bf5d-1ef3-4a36-8dac-dc0a45b72fec, 155b948e-47f5-4741-8e82-2ed65ccfab7d +21NDC 69238-1641, 69097-988, 50228-443 +21Application ANDA212570, ANDA212078, ANDA212722 +9
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 500 tablet, coated in 1 bottle | 46708-480-71 | Alembic PharmaceuticalsIndia | 10 June 2022 |
| 90 tablet, coated in 1 bottle | 46708-480-90 | Alembic PharmaceuticalsIndia | 10 June 2022 |
| 500 tablet, coated in 1 bottle | 62332-480-71 | Alembic PharmaceuticalsIndia | 10 June 2022 |
| 90 tablet, coated in 1 bottle | 62332-480-90 | Alembic PharmaceuticalsIndia | 10 June 2022 |
| 90 tablet, film coated in 1 bottle, plastic | 16729-468-15 | Accord HealthcareIndia | 27 May 2022 |
| 1 bottle in 1 carton / 90 tablet in 1 bottle | 59651-239-90 | Aurobindo PharmaIndia | 11 August 2025 |
| 90 tablet, film coated in 1 bottle | 31722-873-90 | Camber PharmaceuticalsIndia | 21 September 2022 |
| 90 tablet, coated in 1 bottle | 69097-988-05 | CiplaIndia | 2 August 2022 |
| 270 tablet, coated in 1 bottle | 69097-988-93 | CiplaIndia | 2 August 2022 |
| 90 tablet, film coated in 1 bottle | 42385-926-90 | Laurus LabsIndia | 19 July 2022 |
| 90 bottle in 1 carton / 90 tablet, film coated in 1 bottle | 42571-336-90 | Micro LabsIndia | 1 December 2022 |
| 3 bottle in 1 carton / 30 tablet, film coated in 1 bottle | 72205-182-36 | Novadoz PharmaceuticalsIndia | 8 September 2022 |
| 90 tablet, film coated in 1 bottle | 72205-182-90 | Novadoz PharmaceuticalsIndia | 8 September 2022 |
| 1 bottle, plastic in 1 carton / 90 tablet, film coated in 1 bottle, plastic | 60219-1641-9 | Amneal Pharmaceuticals NY | 29 March 2022 |
| 1 bottle, plastic in 1 carton / 90 tablet, film coated in 1 bottle, plastic | 69238-1641-9 | Amneal Pharmaceuticals NY | 28 February 2023 |
| 90 tablet, film coated in 1 bottle | 70954-870-10 | ANI Pharmaceuticals | 19 July 2022 |
| 90 tablet in 1 bottle | 60505-4682-9 | Apotex | 9 April 2024 |
| 90 tablet, film coated in 1 bottle | 82249-116-90 | Civica Script | 2 November 2026 |
| 270 tablet, coated in 1 bottle | 76282-716-27 | Exelan Pharmaceuticals | 2 August 2022 |
| 90 tablet, coated in 1 bottle | 76282-716-90 | Exelan Pharmaceuticals | 2 August 2022 |
| 90 tablet, film coated in 1 bottle, plastic | 0781-8086-92 | Sandoz | 2 May 2022 |
| 500 tablet in 1 bottle | 50228-443-05 | ScieGen Pharmaceuticals | 1 August 2022 |
| 30 tablet in 1 bottle | 50228-443-30 | ScieGen Pharmaceuticals | 1 August 2022 |
| 90 tablet, film coated in 1 bottle | 0480-3611-98 | Teva Pharmaceuticals | 11 May 2022 |
| 90 tablet, coated in 1 bottle | 71335-2984-1 | Bryant Ranch Prepack | 30 October 2025 |
| 90 tablet, coated in 1 bottle | 72162-2466-9 | Bryant Ranch Prepack | 6 March 2025 |
| 1 bottle in 1 carton / 90 tablet, film coated in 1 bottle | 42291-492-09 | AvKARE | 18 October 2023 |
| 90 tablet in 1 bottle | 51407-914-90 | Golden State Medical Supply | 30 April 2024 |
| 90 tablet, film coated in 1 bottle | 0904-7398-89 | Major Pharmaceuticals | 2 March 2024 |
| 90 tablet, film coated in 1 bottle | 72603-259-01 | Northstar Rx | 1 July 2024 |
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 Pirfenidone 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.