Pirfenidone is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Laurus Labs Limited. The primary component is Pirfenidone.
| Product ID | 42385-926_29b0fd0e-5a2b-4da7-8524-177dc28bf55e |
| NDC | 42385-926 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Pirfenidone |
| Generic Name | Pirfenidone |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2022-07-19 |
| Marketing Category | ANDA / |
| Application Number | ANDA212722 |
| Labeler Name | Laurus Labs Limited |
| Substance Name | PIRFENIDONE |
| Active Ingredient Strength | 801 mg/1 |
| Pharm Classes | Pyridone [EPC], Pyridones [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2022-07-19 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0480-3610 | Pirfenidone | Pirfenidone |
| 0480-3611 | Pirfenidone | Pirfenidone |
| 0781-2158 | Pirfenidone | Pirfenidone |
| 0781-8085 | Pirfenidone | Pirfenidone |
| 0781-8086 | Pirfenidone | Pirfenidone |
| 16729-467 | PIRFENIDONE | PIRFENIDONE |
| 16729-468 | PIRFENIDONE | PIRFENIDONE |
| 31722-872 | Pirfenidone | Pirfenidone |
| 31722-873 | Pirfenidone | Pirfenidone |
| 42385-923 | Pirfenidone | Pirfenidone |
| 42385-924 | Pirfenidone | Pirfenidone |
| 42385-925 | Pirfenidone | Pirfenidone |
| 42385-926 | Pirfenidone | Pirfenidone |
| 42571-335 | Pirfenidone | Pirfenidone |
| 42571-336 | Pirfenidone | Pirfenidone |
| 50228-441 | PIRFENIDONE | PIRFENIDONE |
| 50228-442 | PIRFENIDONE | PIRFENIDONE |
| 50228-443 | PIRFENIDONE | PIRFENIDONE |
| 60219-1640 | Pirfenidone | Pirfenidone |
| 60219-1641 | Pirfenidone | Pirfenidone |
| 60219-1642 | Pirfenidone | Pirfenidone |
| 62332-479 | Pirfenidone | Pirfenidone |
| 50242-121 | ESBRIET | PIRFENIDONE |
| 50242-122 | ESBRIET | PIRFENIDONE |
| 50242-123 | ESBRIET | PIRFENIDONE |