PIRFENIDONE
- Product NDC
- 72603-259
- 11-digit product format
- 726030259
- Labeler code
- 72603
- Product ID
- 72603-259_5d0eee8c-dc7d-4444-8684-e9c9335291c8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PIRFENIDONE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northstar Rx LLC
- Application
- ANDA212772
- Marketing category
- ANDA
- Marketing start
- 2022-05-24
- 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 |
|---|
| 72603-259-01 | PIRFENIDONE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72603-259 | PIRFENIDONE TABLET, FILM COATED [NORTHSTAR RX LLC] | 1 | Current NDC, 1 package rows | 20240626_5d0eee8c-dc7d-4444-8684-e9c9335291c8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72603-259-01 | 72603025901 | 90 TABLET, FILM COATED in 1 BOTTLE (72603-259-01) | 2024-07-01 | No | No | Historical |