Leflunomide is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Trigen Laboratories, Llc. The primary component is Leflunomide.
| Product ID | 13811-677_90bcf9c0-f3ca-4634-a6f7-d24f134aaa14 |
| NDC | 13811-677 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Leflunomide |
| Generic Name | Leflunomide |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2011-05-06 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA091369 |
| Labeler Name | Trigen Laboratories, LLC |
| Substance Name | LEFLUNOMIDE |
| Active Ingredient Strength | 10 mg/1 |
| Pharm Classes | Antirheumatic Agent [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2011-05-06 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA091369 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-05-06 |
| Marketing End Date | 2019-12-31 |
| Marketing Category | ANDA |
| Application Number | ANDA091369 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2011-05-06 |
| Marketing End Date | 2019-12-31 |
| Marketing Category | ANDA |
| Application Number | ANDA091369 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-05-06 |
| Marketing End Date | 2019-12-31 |
| Marketing Category | ANDA |
| Application Number | ANDA091369 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-05-06 |
| Marketing End Date | 2019-12-31 |
| Ingredient | Strength |
|---|---|
| LEFLUNOMIDE | 10 mg/1 |
| SPL SET ID: | 332aeb48-8a1a-4d50-be12-05411b7a2967 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0955-1735 | Leflunomide | leflunomide |
| 0955-1737 | Leflunomide | leflunomide |
| 10702-277 | Leflunomide | Leflunomide |
| 10702-278 | Leflunomide | Leflunomide |
| 13811-677 | Leflunomide | Leflunomide |
| 13811-678 | Leflunomide | Leflunomide |
| 23155-043 | Leflunomide | Leflunomide |
| 68258-2992 | Leflunomide | Leflunomide |
| 23155-044 | Leflunomide | Leflunomide |
| 46708-437 | Leflunomide | Leflunomide |
| 46708-436 | Leflunomide | Leflunomide |
| 60505-2503 | LEFLUNOMIDE | LEFLUNOMIDE |
| 60505-2502 | LEFLUNOMIDE | LEFLUNOMIDE |
| 62332-062 | Leflunomide | Leflunomide |
| 62332-061 | Leflunomide | Leflunomide |
| 70710-1157 | leflunomide | leflunomide |
| 70710-1158 | leflunomide | leflunomide |
| 70771-1492 | leflunomide | leflunomide |
| 70771-1491 | leflunomide | leflunomide |
| 42291-420 | LEFLUNOMIDE | LEFLUNOMIDE |
| 42291-421 | LEFLUNOMIDE | LEFLUNOMIDE |
| 70748-130 | Leflunomide | Leflunomide |
| 70748-129 | Leflunomide | Leflunomide |
| 50268-477 | LEFLUNOMIDE | LEFLUNOMIDE |
| 50268-478 | LEFLUNOMIDE | LEFLUNOMIDE |
| 0088-2160 | Arava | leflunomide |
| 0088-2161 | Arava | leflunomide |
| 0088-2162 | Arava | leflunomide |