Pirfenidone
- Product NDC
- 69238-1641
- 11-digit product format
- 692381641
- Labeler code
- 69238
- Product ID
- 69238-1641_08b2264e-d081-4558-9893-0a11d25e7a39
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pirfenidone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA212570
- Marketing category
- ANDA
- Marketing start
- 2023-02-28
- 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 |
|---|
| 69238-1641-9 | 69238164109 | 1 BOTTLE, PLASTIC in 1 CARTON (69238-1641-9) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2023-02-28 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Pirfenidone | Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals of New York, LLC | 2023-04-10 | HUMAN PRESCRIPTION DRUG LABEL | 2 |