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Xtandi
Xtandi - 0469-0125-99 - (enzalutamide)
Drug Information of Xtandi
| Product NDC: | 0469-0125 |
| Proprietary Name: | Xtandi |
| Non Proprietary Name: | enzalutamide |
| Active Ingredient(s): | 40 mg/1 & nbsp; enzalutamide |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Xtandi
| Product NDC: | 0469-0125 |
| Labeler Name: | Astellas Pharma US, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA203415 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20120831 |
Package Information of Xtandi
| Package NDC: | 0469-0125-99 |
| Package Description: | 1 BOTTLE in 1 CARTON (0469-0125-99) > 120 CAPSULE in 1 BOTTLE |
NDC Information of Xtandi
| NDC Code | 0469-0125-99 |
| Proprietary Name | Xtandi |
| Package Description | 1 BOTTLE in 1 CARTON (0469-0125-99) > 120 CAPSULE in 1 BOTTLE |
| Product NDC | 0469-0125 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | enzalutamide |
| Dosage Form Name | CAPSULE |
| Route Name | ORAL |
| Start Marketing Date | 20120831 |
| Marketing Category Name | NDA |
| Labeler Name | Astellas Pharma US, Inc. |
| Substance Name | ENZALUTAMIDE |
| Strength Number | 40 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Androgen Receptor Inhibitor [EPC],Androgen Receptor Antagonists [MoA],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] |
