Pirfenidone
- Product NDC
- 59651-244
- 11-digit product format
- 596510244
- Labeler code
- 59651
- Product ID
- 59651-244_3115f15f-171c-4266-8dc8-5655f56e6acc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pirfenidone
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA212597
- Marketing category
- ANDA
- Marketing start
- 2026-04-20
- Substance
- PIRFENIDONE
- Active strength
- 267 mg/1
- Pharmacologic classes
- Pyridone [EPC], Pyridones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pirfenidone
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PIRFENIDONE | 267 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D7NLD2JX7U |
| Rxcui | 1592279 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-244-27 | 59651024427 | 1 BOTTLE in 1 CARTON (59651-244-27) / 270 CAPSULE in 1 BOTTLE | 1 bottle | 2026-04-20 | No | No | Current |
| 59651-244-28 | 59651024428 | 4 BLISTER PACK in 1 CARTON (59651-244-28) / 63 CAPSULE in 1 BLISTER PACK (59651-244-63) | 4 blister pack | 2026-04-20 | No | No | Current |
| 59651-244-42 | 59651024442 | 1 BLISTER PACK in 1 CARTON (59651-244-42) / 63 CAPSULE in 1 BLISTER PACK | 1 blister pack | 2026-04-20 | No | No | Current |
| 59651-244-63 | 59651024463 | 63 in 1 BLISTER PACK | | | | | Historical |