PIRFENIDONE
- Product NDC
- 0904-7397
- 11-digit product format
- 009047397
- Labeler code
- 0904
- Product ID
- 0904-7397_73db516f-8c80-431f-8190-33081718cf8d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PIRFENIDONE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- MAJOR PHARMACEUTICALS
- Application
- ANDA212772
- Marketing category
- ANDA
- Marketing start
- 2022-05-24
- 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, 1868018 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7397-53 | PIRFENIDONE | 3 in 1 CARTON | TABLET, FILM COATED | 3 | | 1 |
| 0904-7397-89 | 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 |
|---|
| 0904-7397 | PIRFENIDONE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | Current NDC, 2 package rows | 20240303_73db516f-8c80-431f-8190-33081718cf8d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7397-53 | 00904739753 | 3 BOTTLE in 1 CARTON (0904-7397-53) / 90 TABLET, FILM COATED in 1 BOTTLE (0904-7397-89) | 3 bottle | 2024-03-02 | No | No | Current |
| 0904-7397-89 | 00904739789 | 90 in 1 BOTTLE | | | | | Historical |