NDC 0469-0625
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 | 0469-0625_25c3a7dd-b2f0-4188-a4c3-9ccc694ca7a9 |
| NDC | 0469-0625 |
| 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 / NDA |
| Application Number | NDA213674 |
| Labeler Name | Astellas Pharma US, Inc. |
| Substance Name | ENZALUTAMIDE |
| Active Ingredient Strength | 40 mg/1 |
| Pharm Classes | Androgen Receptor Inhibitor [EPC],Androgen Receptor Antagonists [MoA],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
Packaging
NDC 0469-0625-99
1 BOTTLE in 1 CARTON (0469-0625-99) > 120 TABLET in 1 BOTTLE
| Marketing Start Date | 2020-08-04 |
| NDC Exclude Flag | N |
| Sample Package? | N |
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 |
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