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NDC 00469-0725-60 Xtandi 80 mg/1 Details
Xtandi 80 mg/1
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.
MedlinePlus Drug Summary
Enzalutamide is used to treat prostate cancer that has spread to other parts of the body in men and who have been helped by certain medical and surgical treatments that decrease testosterone levels. It is also used to treat prostate cancer in men who have not been helped by certain medical and surgical treatments that decrease testosterone levels. Enzalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells.
Related Packages: 00469-0725-60Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Enzalutamide
Product Information
| NDC | 00469-0725 |
|---|---|
| Product ID | 0469-0725_bddcc9f9-afad-4b83-a6d7-551f3cfd9cdb |
| Associated GPIs | 21402430000340 |
| GCN Sequence Number | 081367 |
| GCN Sequence Number Description | enzalutamide TABLET 80 MG ORAL |
| HIC3 | V1J |
| HIC3 Description | ANTINEOPLASTIC - ANTIANDROGENIC AGENTS |
| GCN | 48452 |
| HICL Sequence Number | 039580 |
| HICL Sequence Number Description | ENZALUTAMIDE |
| Brand/Generic | Brand |
| Proprietary Name | Xtandi |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | enzalutamide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 80 |
| Active Ingredient Units | mg/1 |
| Substance Name | ENZALUTAMIDE |
| Labeler Name | Astellas Pharma US, Inc. |
| Pharmaceutical Class | Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA213674 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00469-0725-60 (00469072560)
| NDC Package Code | 0469-0725-60 |
|---|---|
| Billing NDC | 00469072560 |
| Package | 1 BOTTLE in 1 CARTON (0469-0725-60) / 60 TABLET in 1 BOTTLE |
| Marketing Start Date | 2020-08-04 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |