Teriflunomide is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Ny Llc. The primary component is Teriflunomide.
| Product ID | 69238-1303_3cdb678e-3c0f-4331-a8d7-288741384e32 |
| NDC | 69238-1303 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Teriflunomide |
| Generic Name | Teriflunomide |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2018-10-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA209613 |
| Labeler Name | Amneal Pharmaceuticals NY LLC |
| Substance Name | TERIFLUNOMIDE |
| Active Ingredient Strength | 7 mg/1 |
| Pharm Classes | Pyrimidine Synthesis Inhibitor [EPC],Dihydroorotate Dehydrogenase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2018-10-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA209613 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-10-01 |
| Marketing Category | ANDA |
| Application Number | ANDA209613 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-10-01 |
| Ingredient | Strength |
|---|---|
| TERIFLUNOMIDE | 7 mg/1 |
| SPL SET ID: | 1f054d91-aede-4c1a-9aba-04f40d11e4d1 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0115-1565 | Teriflunomide | Teriflunomide |
| 68462-311 | teriflunomide | teriflunomide |
| 68462-312 | teriflunomide | teriflunomide |
| 69238-1303 | Teriflunomide | Teriflunomide |
| 69238-1304 | Teriflunomide | Teriflunomide |
| 69539-032 | Teriflunomide | Teriflunomide |
| 69539-033 | Teriflunomide | Teriflunomide |
| 58468-0210 | Aubagio | teriflunomide |
| 58468-0211 | Aubagio | teriflunomide |