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NDC 63629-8308-01 Bicalutamide 50 mg/1 Details
Bicalutamide 50 mg/1
Bicalutamide is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is BICALUTAMIDE.
MedlinePlus Drug Summary
Bicalutamide is used with another medication (gonadotropin-releasing hormone (GnRH) agonists; such as leuprolide or goserelin) to treat metastatic prostate cancer (cancer that started in the prostate and has spread to other parts of the body). Bicalutamide is in a class of medications called nonsteroidal antiandrogens. It works by blocking the effect of androgen (a male hormone), to stop the growth and spread of cancer cells.
Related Packages: 63629-8308-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bicalutamide
Product Information
| NDC | 63629-8308 |
|---|---|
| Product ID | 63629-8308_cf499d7f-2681-49f7-9dd9-02d57933baee |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Bicalutamide |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Bicalutamide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/1 |
| Substance Name | BICALUTAMIDE |
| Labeler Name | Bryant Ranch Prepack |
| Pharmaceutical Class | Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA078917 |
| Listing Certified Through | 2022-12-31 |
Package
NDC 63629-8308-01 (63629830801)
| NDC Package Code | 63629-8308-1 |
|---|---|
| Billing NDC | 63629830801 |
| Package | 30 TABLET in 1 BOTTLE (63629-8308-1) |
| Marketing Start Date | 2009-07-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |