Active ingredient
Pirfenidone
61 finished FDA listings contain Pirfenidone as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PIRFENIDONE
- Dosage forms
- Capsule, Tablet, Tablet, Coated, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 24
- Strengths listed
- 267 mg/1 · 534 mg/1 · 801 mg/1
- Brand names in FDA listings
- Esbriet
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1592254
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 208780 | LEGACY | 2017-01-11 | 4 |
| ANDA 212569 | AMNEAL | 2022-01-03 | 3 |
| ANDA 212730 | ACCORD HLTHCARE | 2022-01-25 | 2 |
| ANDA 212759 | TEVA PHARMS USA | 2022-01-25 | 2 |
| ANDA 212570 | AMNEAL | 2022-03-25 | 6 |
| ANDA 212560 | SANDOZ | 2022-04-28 | 2 |
| ANDA 212680 | MICRO LABS | 2022-05-18 | 2 |
| ANDA 212708 | ALEMBIC | 2022-05-20 | 8 |
| ANDA 212772 | MSN | 2022-05-24 | 6 |
| ANDA 212600 | SANDOZ | 2022-06-13 | 1 |
| ANDA 212722 | LAURUS | 2022-07-19 | 5 |
| ANDA 212724 | LAURUS | 2022-07-19 | 1 |
| ANDA 212078 | SCIEGEN PHARMS | 2022-08-01 | 6 |
| ANDA 212077 | SCIEGEN PHARMS | 2022-08-01 | 3 |
| ANDA 212674 | HETERO LABS LTD V | 2022-09-21 | 2 |
| ANDA 212709 | APOTEX | 2023-05-31 | 4 |
| ANDA 212748 | MACLEODS PHARMS | 2024-12-18 | 1 |
| ANDA 212596 | AUROBINDO PHARMA | 2025-08-11 | 2 |
| ANDA 212597 | AUROBINDO PHARMA | 2026-04-20 | 1 |
Official labeling on DailyMed
- PIRFENIDONE TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.] · version 6 · 2026-08-21
- PIRFENIDONE CAPSULE [AUROBINDO PHARMA LIMITED] · version 1 · 2026-04-29
- PIRFENIDONE CAPSULE [AVKARE] · version 3 · 2026-01-16
- PIRFENIDONE TABLET, FILM COATED [AVKARE] · version 2 · 2026-01-16
- PIRFENIDONE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] · version 9 · 2025-12-19
- ESBRIET (PIRFENIDONE) CAPSULE ESBRIET (PIRFENIDONE) TABLET, COATED [GENENTECH, INC.] · version 21 · 2025-12-18
- PIRFENIDONE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 2 · 2025-12-08
- PIRFENIDONE TABLET, COATED [BRYANT RANCH PREPACK] · version 100 · 2025-11-17
- PIRFENIDONE TABLET, COATED [BRYANT RANCH PREPACK] · version 100 · 2025-11-17
- PIRFENIDONE TABLET, FILM COATED [ANI PHARMACEUTICALS, INC.] · version 6 · 2025-09-19
- PIRFENIDONE TABLET [AUROBINDO PHARMA LIMITED] · version 1 · 2025-08-22
- PIRFENIDONE TABLET, COATED [BRYANT RANCH PREPACK] · version 105 · 2025-08-11
Showing the 12 most recent of 34 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.