DEA schedule
Is pirfenidone a controlled substance?
Federal schedule for pirfenidone from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
No. Pirfenidone is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and pirfenidone is not on the DEA controlled substances list.
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 61 prescription listings from 24 labelers, none with a DEA schedule |
| DEA controlled substances list | pirfenidone is not on the list |
Pirfenidone NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 50242-122 | ESBRIET | tablet, coated | 267 mg/1 | Genentech, Inc. | None |
| 83107-028 | ESBRIET | tablet, coated | 267 mg/1 | Legacy Pharma USA Inc. | None |
| 50242-123 | ESBRIET | tablet, coated | 801 mg/1 | Genentech, Inc. | None |
| 83107-029 | ESBRIET | tablet, coated | 801 mg/1 | Legacy Pharma USA Inc. | None |
| 0781-2158 | Pirfenidone | capsule | 267 mg/1 | Sandoz Inc | None |
| 42291-490 | Pirfenidone | capsule | 267 mg/1 | AvKARE | None |
| 42385-923 | Pirfenidone | capsule | 267 mg/1 | Laurus Labs Limited | None |
| 50228-441 | PIRFENIDONE | capsule | 267 mg/1 | ScieGen Pharmaceuticals, Inc. | None |
| 59651-244 | Pirfenidone | capsule | 267 mg/1 | Aurobindo Pharma Limited | None |
| 60219-1642 | Pirfenidone | capsule | 267 mg/1 | Amneal Pharmaceuticals NY LLC | None |
| 69097-940 | PIRFENIDONE | capsule | 267 mg/1 | Cipla USA Inc. | None |
| 69238-1642 | Pirfenidone | capsule | 267 mg/1 | Amneal Pharmaceuticals NY LLC | None |
| 76282-715 | PIRFENIDONE | capsule | 267 mg/1 | EXELAN PHARMACEUTICALS INC. | None |
| 50228-442 | PIRFENIDONE | tablet | 267 mg/1 | ScieGen Pharmaceuticals, Inc. | None |
| 51407-913 | Pirfenidone | tablet | 267 mg/1 | Golden State Medical Supply, Inc. | None |
| 59651-238 | Pirfenidone | tablet | 267 mg/1 | Aurobindo Pharma Limited | None |
| 60505-4681 | Pirfenidone | tablet | 267 mg/1 | Apotex Corp. | None |
| 50228-443 | PIRFENIDONE | tablet | 801 mg/1 | ScieGen Pharmaceuticals, Inc. | None |
| 51407-914 | Pirfenidone | tablet | 801 mg/1 | Golden State Medical Supply, Inc. | None |
| 59651-239 | Pirfenidone | tablet | 801 mg/1 | Aurobindo Pharma Limited | None |
| 60505-4682 | Pirfenidone | tablet | 801 mg/1 | Apotex Corp. | None |
| 46708-479 | Pirfenidone | tablet, coated | 267 mg/1 | Alembic Pharmaceuticals Limited | None |
| 62332-479 | Pirfenidone | tablet, coated | 267 mg/1 | Alembic Pharmaceuticals Inc. | None |
| 69097-987 | Pirfenidone | tablet, coated | 267 mg/1 | Cipla USA Inc. | None |
| 71335-2944 | Pirfenidone | tablet, coated | 267 mg/1 | Bryant Ranch Prepack | None |
| 72162-2465 | Pirfenidone | tablet, coated | 267 mg/1 | Bryant Ranch Prepack | None |
| 76282-717 | Pirfenidone | tablet, coated | 267 mg/1 | EXELAN PHARMACEUTICALS INC. | None |
| 46708-480 | Pirfenidone | tablet, coated | 801 mg/1 | Alembic Pharmaceuticals Limited | None |
| 62332-480 | Pirfenidone | tablet, coated | 801 mg/1 | Alembic Pharmaceuticals Inc. | None |
| 69097-988 | Pirfenidone | tablet, coated | 801 mg/1 | Cipla USA Inc. | None |
| 71335-2984 | Pirfenidone | tablet, coated | 801 mg/1 | Bryant Ranch Prepack | None |
| 72162-2466 | Pirfenidone | tablet, coated | 801 mg/1 | Bryant Ranch Prepack | None |
| 76282-716 | Pirfenidone | tablet, coated | 801 mg/1 | EXELAN PHARMACEUTICALS INC. | None |
| 0480-3610 | Pirfenidone | tablet, film coated | 267 mg/1 | Teva Pharmaceuticals, Inc. | None |
| 0781-8085 | Pirfenidone | tablet, film coated | 267 mg/1 | Sandoz Inc | None |
| 0904-7397 | PIRFENIDONE | tablet, film coated | 267 mg/1 | MAJOR PHARMACEUTICALS | None |
| 16729-467 | PIRFENIDONE | tablet, film coated | 267 mg/1 | Accord Healthcare Inc. | None |
| 31722-872 | Pirfenidone | tablet, film coated | 267 mg/1 | Camber Pharmaceuticals, Inc. | None |
| 42291-491 | Pirfenidone | tablet, film coated | 267 mg/1 | AvKARE | None |
| 42385-924 | Pirfenidone | tablet, film coated | 267 mg/1 | Laurus Labs Limited | None |
Showing 40 of 61 listings.
Questions
Is pirfenidone a controlled substance?
No. Pirfenidone is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and pirfenidone is not on the DEA controlled substances list.
Is pirfenidone a narcotic?
No. Pirfenidone is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is Pyridone.
Does this page cover state schedules?
No. This page reports the federal schedule only. Some states schedule drugs on their own; check your state board of pharmacy.