Pirfenidone
- Product NDC
- 71335-2984
- 11-digit product format
- 713352984
- Labeler code
- 71335
- Product ID
- 71335-2984_c7d17735-c06d-435d-93da-52935e61442c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pirfenidone
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA212708
- Marketing category
- ANDA
- Marketing start
- 2022-06-10
- Substance
- PIRFENIDONE
- Active strength
- 801 mg/1
- Pharmacologic classes
- Pyridone [EPC], Pyridones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| D7NLD2JX7U | PIRFENIDONE | 53179-13-8 | PIRFENIDONE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2984-1 | 71335298401 | 90 TABLET, COATED in 1 BOTTLE (71335-2984-1) | 2025-10-30 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Pirfenidone | Bryant Ranch Prepack | 2025-10-30 | HUMAN PRESCRIPTION DRUG LABEL | 100 |