PIRFENIDONE
- Product NDC
- 50228-443
- 11-digit product format
- 502280443
- Labeler code
- 50228
- Product ID
- 50228-443_09af4fec-e2cf-2c8d-e063-6294a90af999
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PIRFENIDONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ScieGen Pharmaceuticals, Inc.
- Application
- ANDA212078
- Marketing category
- ANDA
- Marketing start
- 2022-08-01
- 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 | 1868014, 1868018 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50228-443-05 | PIRFENIDONE | 500 in 1 BOTTLE | TABLET | 500 | | 2 |
| 50228-443-30 | PIRFENIDONE | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50228-443 | PIRFENIDONE TABLET [SCIEGEN PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20231109_155b948e-47f5-4741-8e82-2ed65ccfab7d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50228-443-05 | 50228044305 | 500 TABLET in 1 BOTTLE (50228-443-05) | 500 tablet | 2022-08-01 | 0000-00-00 | No | No | Current |
| 50228-443-30 | 50228044330 | 30 TABLET in 1 BOTTLE (50228-443-30) | 30 tablet | 2022-08-01 | 0000-00-00 | No | No | Current |