NDC 0469-1725
Xtandi
Enzalutamide
Xtandi is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Astellas Pharma Us, Inc.. The primary component is Enzalutamide.
| Product ID | 0469-1725_2b95b0cc-a568-4587-9a46-39c72e892942 |
| NDC | 0469-1725 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Xtandi |
| Generic Name | Enzalutamide |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-08-04 |
| Marketing Category | NDA / |
| Application Number | NDA213674 |
| Labeler Name | Astellas Pharma US, Inc. |
| Substance Name | ENZALUTAMIDE |
| Active Ingredient Strength | 40 mg/1 |
| Pharm Classes | Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 0469-1725-56
1 BOTTLE in 1 CARTON (0469-1725-56) > 56 TABLET in 1 BOTTLE
| Marketing Start Date | 2020-08-04 |
| NDC Exclude Flag | N |
| Sample Package? | Y |
Drug Details
NDC Crossover Matching brand name "Xtandi" or generic name "Enzalutamide"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0469-0125 | Xtandi | enzalutamide |
| 0469-0625 | Xtandi | enzalutamide |
| 0469-0725 | Xtandi | enzalutamide |
| 0469-1125 | Xtandi | enzalutamide |
| 0469-1725 | Xtandi | enzalutamide |
Trademark Results [Xtandi]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 XTANDI 79110148 4181564 Live/Registered |
Astellas Pharma Inc. 2011-12-27 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.