Pirfenidone
- Product NDC
- 71335-2984
- 11-digit product format
- 713352984
- Labeler code
- 71335
- Product ID
- 71335-2984_c7d17735-c06d-435d-93da-52935e61442c
- 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
- 801 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 | 801 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D7NLD2JX7U |
| Rxcui | 1868018 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-2984-1 | 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2984-1 | 71335298401 | 90 TABLET, COATED in 1 BOTTLE (71335-2984-1) | 2025-10-30 | No | No | Current |