Pirfenidone
- Product NDC
- 59651-238
- 11-digit product format
- 596510238
- Labeler code
- 59651
- Product ID
- 59651-238_50958060-c904-4374-997d-59df54007fa4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pirfenidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA212596
- Marketing category
- ANDA
- Marketing start
- 2025-08-11
- Substance
- PIRFENIDONE
- Active strength
- 267 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-238-27 | 59651023827 | 3 BOTTLE in 1 CARTON (59651-238-27) / 90 TABLET in 1 BOTTLE (59651-238-90) | 3 bottle | 2025-08-11 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Pirfenidone | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 2025-08-13 | Human Prescription Drug Label | 1 |