Pirfenidone
- Product NDC
- 69238-1642
- 11-digit product format
- 692381642
- Labeler code
- 69238
- Product ID
- 69238-1642_d7214722-7cee-4a8a-9b9e-8955333a1146
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pirfenidone
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA212569
- Marketing category
- ANDA
- Marketing start
- 2022-01-07
- 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 |
|---|
| 69238-1642-7 | 69238164207 | 1 BOTTLE in 1 CARTON (69238-1642-7) / 270 CAPSULE in 1 BOTTLE | 1 bottle | 2022-01-07 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Pirfenidone | Amneal Pharmaceuticals NY LLC | 2024-11-04 | HUMAN PRESCRIPTION DRUG LABEL | 3 |