Pirfenidone
- Product NDC
- 71335-2944
- 11-digit product format
- 713352944
- Labeler code
- 71335
- Product ID
- 71335-2944_3da3b5d3-96f8-46f2-a763-a3f5debac032
- 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
- 267 mg/1
- Pharmacologic classes
- Pyridone [EPC], Pyridones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pirfenidone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PIRFENIDONE | 267 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D7NLD2JX7U |
| Rxcui | 1868014 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-2944-1 | Pirfenidone | 3 in 1 CARTON | TABLET, COATED | 3 | | 100 |
| 71335-2944-1 | Pirfenidone | 90 in 1 BOTTLE | TABLET, COATED | 90 | | 100 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2944-1 | 71335294401 | 3 BOTTLE in 1 CARTON (71335-2944-1) / 90 TABLET, COATED in 1 BOTTLE | 3 bottle | 2025-10-30 | No | No | Current |