Pirfenidone
- Product NDC
- 72162-2466
- 11-digit product format
- 721622466
- Labeler code
- 72162
- Product ID
- 72162-2466_1b6d782c-c1a3-42fd-97a2-37b4a6cf7334
- 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 |
|---|
| 72162-2466-9 | Pirfenidone | 90 in 1 BOTTLE | TABLET, COATED | 90 | | 101 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72162-2466 | PIRFENIDONE TABLET, COATED [BRYANT RANCH PREPACK] | 100 | Current NDC, 1 package rows | 20250309_bfcb3157-cfa1-493d-9598-1e7fd3d355d9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72162-2466-9 | 72162246609 | 90 TABLET, COATED in 1 BOTTLE (72162-2466-9) | 2025-03-06 | No | No | Current |