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NDC 50419-0395-72 NUBEQA 300 mg/1 Details
NUBEQA 300 mg/1
NUBEQA is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bayer HealthCare Pharmaceuticals Inc.. The primary component is DAROLUTAMIDE.
MedlinePlus Drug Summary
Darolutamide is used to treat certain types of prostate cancer (cancer that begins in the prostate [a male reproductive gland]) that has not spread to other parts of the body in men who have not been helped by other medical treatments. Darolutamide is also used to treat certain types of prostate cancer (cancer that begins in the prostate [a male reproductive gland]) that have spread to other parts of the body in men in combination with docetaxel. Darolutamide 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: 50419-0395-72Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Darolutamide
Product Information
| NDC | 50419-0395 |
|---|---|
| Product ID | 50419-395_78565601-df32-45a6-9d08-ac84738c8963 |
| Associated GPIs | 21402425000320 |
| GCN Sequence Number | 080069 |
| GCN Sequence Number Description | darolutamide TABLET 300 MG ORAL |
| HIC3 | V1J |
| HIC3 Description | ANTINEOPLASTIC - ANTIANDROGENIC AGENTS |
| GCN | 46746 |
| HICL Sequence Number | 045909 |
| HICL Sequence Number Description | DAROLUTAMIDE |
| Brand/Generic | Brand |
| Proprietary Name | NUBEQA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | darolutamide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 300 |
| Active Ingredient Units | mg/1 |
| Substance Name | DAROLUTAMIDE |
| Labeler Name | Bayer HealthCare Pharmaceuticals Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA212099 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50419-0395-72 (50419039572)
| NDC Package Code | 50419-395-72 |
|---|---|
| Billing NDC | 50419039572 |
| Package | 1 BOTTLE in 1 CARTON (50419-395-72) / 120 TABLET, FILM COATED in 1 BOTTLE |
| Marketing Start Date | 2021-03-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |