Pirfenidone
- Product NDC
- 46708-479
- 11-digit product format
- 467080479
- Labeler code
- 46708
- Product ID
- 46708-479_5dd2966d-35b0-4a80-a677-bca6f4c69311
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pirfenidone
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA212708
- Marketing category
- ANDA
- Marketing start
- 2022-06-10
- 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 |
|---|
| 46708-479-27 | 46708047927 | 270 TABLET, COATED in 1 BOTTLE (46708-479-27) | | 2022-11-22 | No | No | Historical |
| 46708-479-64 | 46708047964 | 3 BOTTLE in 1 CARTON (46708-479-64) / 90 TABLET, COATED in 1 BOTTLE | 3 bottle | 2022-06-10 | No | No | Historical |
| 46708-479-71 | 46708047971 | 500 TABLET, COATED in 1 BOTTLE (46708-479-71) | | 2022-06-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Pirfenidone | Alembic Pharmaceuticals Limited | 2023-03-30 | Human Prescription Drug Label | 3 |