Pirfenidone
- Product NDC
- 59651-239
- 11-digit product format
- 596510239
- Labeler code
- 59651
- Product ID
- 59651-239_50958060-c904-4374-997d-59df54007fa4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pirfenidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA212596
- Marketing category
- ANDA
- Marketing start
- 2025-08-11
- 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 |
|---|
| 59651-239-90 | Pirfenidone | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
| 59651-239-90 | Pirfenidone | 1 in 1 CARTON | TABLET | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-239-90 | 59651023990 | 1 BOTTLE in 1 CARTON (59651-239-90) / 90 TABLET in 1 BOTTLE | 1 bottle | 2025-08-11 | No | No | Current |