Stivarga Tablet, Film Coated
NDC Package 50419-171-00

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

Stivarga (regorafenib) tablets is regorafenib is used to treat cancer of the colon and rectum. This formulation utilizes a tablet, film coated delivery system. Marketed by Bayer Healthcare Pharmaceuticals Inc., this product is identified by NDC 50419-171 and is authorized under FDA application NDA203085.

Identification & Billing

NDC Package Code
50419-171-00
Package Description
210 BOTTLE in 1 BOX / 28 TABLET, FILM COATED in 1 BOTTLE
Product Code
50419-171
11-Digit Billing Format
50419017100
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Stivarga
Non-Proprietary Name
Regorafenib
Substance Name
Regorafenib
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)
REGORAFENIB 40 mg/1
Pharmacologic Class
Usage Information
Regorafenib is used to treat cancer of the colon and rectum. It is also used to treat liver cancer and a certain cancer of the digestive system (gastrointestinal stromal tumor). It works by slowing or stopping the growth of cancer cells.

Regulatory & Marketing

Labeler Name
Bayer Healthcare Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA203085
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-27-2012
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 (50419-171). Click a package code to view its specific billing and regulatory data.

50419-171-03
3 BOTTLE, PLASTIC in 1 BOX / 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-01)
50419-171-04
1 BOTTLE, PLASTIC in 1 CARTON / 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
50419-171-06
4 BOTTLE, PLASTIC in 1 CARTON / 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-05)

* 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 50419-171-00 identifies a specific commercial package of 210 bottle in 1 box / 28 tablet, film coated in 1 bottle of Stivarga, a human prescription drug labeled by Bayer Healthcare Pharmaceuticals Inc.. This tablet, film coated is formulated for oral use and contains regorafenib 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 September 27, 2012. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Regorafenib is used to treat cancer of the colon and rectum. It is also used to treat liver cancer and a certain cancer of the digestive system (gastrointestinal stromal tumor). It works by slowing or stopping the growth of cancer cells.

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: 50419017100. 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)
50419-171-00
11-Digit CMS (5-4-2)
50419-0171-00

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