Nubeqa Tablet, Film Coated
NDC Package 50419-395-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Nubeqa (darolutamide) tablets is darolutamide is used to treat a certain type of prostate cancer. This formulation utilizes a tablet, film coated delivery system. Marketed by Bayer Healthcare Pharmaceuticals Inc., this product is identified by NDC 50419-395 and is authorized under FDA application NDA212099.

Identification & Billing

NDC Package Code
50419-395-01
Package Description
1 BOTTLE in 1 CARTON / 120 TABLET, FILM COATED in 1 BOTTLE
Product Code
50419-395
11-Digit Billing Format
50419039501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nubeqa
Non-Proprietary Name
Darolutamide
Substance Name
Darolutamide
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DAROLUTAMIDE 300 mg/1
Usage Information
Darolutamide is used to treat a certain type of prostate cancer. This medication belongs to a class of drugs known as anti-androgens (anti-testosterone). It works by blocking the effects of testosterone to slow the growth and spread of prostate cancer.

Regulatory & Marketing

Labeler Name
Bayer Healthcare Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA212099
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-31-2019
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (50419-395). Click a package code to view its specific billing and regulatory data.

50419-395-72
1 BOTTLE in 1 CARTON / 120 TABLET, FILM COATED in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50419-395-01 identifies a specific commercial package of 1 bottle in 1 carton / 120 tablet, film coated in 1 bottle of Nubeqa, a human prescription drug labeled by Bayer Healthcare Pharmaceuticals Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This tablet, film coated is formulated for oral use and contains darolutamide as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Bayer Healthcare Pharmaceuticals Inc. on July 31, 2019. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Darolutamide is used to treat a certain type of prostate cancer. This medication belongs to a class of drugs known as anti-androgens (anti-testosterone). It works by blocking the effects of testosterone to slow the growth and spread of prostate cancer.

How is this Bayer Healthcare Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50419039501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
50419-395-01
11-Digit CMS (5-4-2)
50419-0395-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.