Febuxostat is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Febuxostat.
| Product ID | 0378-3926_3f5600cd-1f2f-410a-8c55-b8363d4fc492 |
| NDC | 0378-3926 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Febuxostat |
| Generic Name | Febuxostat |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-07-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA205385 |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Substance Name | FEBUXOSTAT |
| Active Ingredient Strength | 80 mg/1 |
| Pharm Classes | Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2019-07-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA205385 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-07-01 |
| Ingredient | Strength |
|---|---|
| FEBUXOSTAT | 80 mg/1 |
| SPL SET ID: | 3f5600cd-1f2f-410a-8c55-b8363d4fc492 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0054-0413 | Febuxostat | Febuxostat |
| 0054-0414 | Febuxostat | Febuxostat |
| 0378-3925 | Febuxostat | febuxostat |
| 0378-3926 | Febuxostat | febuxostat |
| 0527-2244 | FEBUXOSTAT | febuxostat |
| 0527-2248 | FEBUXOSTAT | febuxostat |
| 14445-156 | Febuxostat | Febuxostat |
| 14445-157 | Febuxostat | Febuxostat |
| 16714-059 | Febuxostat | Febuxostat |
| 16714-060 | Febuxostat | Febuxostat |
| 27808-206 | Febuxostat | febuxostat |
| 27808-207 | Febuxostat | febuxostat |
| 43547-295 | FEBUXOSTAT | febuxostat |
| 43547-296 | FEBUXOSTAT | febuxostat |
| 46708-190 | Febuxostat | febuxostat |
| 46708-191 | Febuxostat | febuxostat |
| 47335-721 | Febuxostat | Febuxostat |
| 47335-722 | Febuxostat | Febuxostat |
| 48792-7905 | FEBUXOSTAT | febuxostat |
| 48792-7906 | FEBUXOSTAT | febuxostat |
| 51407-293 | Febuxostat | Febuxostat |
| 51407-294 | Febuxostat | Febuxostat |
| 55111-796 | Febuxostat | Febuxostat |
| 55111-797 | Febuxostat | Febuxostat |
| 60687-538 | Febuxostat | Febuxostat |
| 62332-190 | Febuxostat | febuxostat |
| 62332-191 | Febuxostat | febuxostat |
| 63304-864 | Febuxostat | Febuxostat |
| 63304-865 | Febuxostat | Febuxostat |
| 69539-036 | Febuxostat | Febuxostat |
| 69539-035 | Febuxostat | Febuxostat |
| 71610-386 | Febuxostat | Febuxostat |
| 71610-411 | Febuxostat | Febuxostat |
| 72205-028 | Febuxostat | Febuxostat |
| 72205-029 | Febuxostat | Febuxostat |
| 71610-450 | Febuxostat | Febuxostat |
| 68071-5271 | Febuxostat | Febuxostat |
| 21695-516 | ULORIC | febuxostat |
| 43353-305 | ULORIC | febuxostat |
| 55154-5158 | ULORIC | febuxostat |
| 55154-5159 | ULORIC | febuxostat |