Regorafenib Tablet, Film Coated
NDC Package 12527-0171-9

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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 Ag, this product is identified by NDC 12527-0171.

Identification & Billing

NDC Package Code
12527-0171-9
Package Description
63559 TABLET, FILM COATED in 1 DRUM
Product Code
12527-0171
11-Digit Billing Format
12527017109

Clinical Specifications

Proprietary Name
Regorafenib
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.
Active Ingredient(s)
REGORAFENIB 40 mg/1
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 Ag
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
09-01-2018
Listing Expiration
12-31-2027
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 12527-0171-9 identifies a specific commercial package of 63559 tablet, film coated in 1 drum of Regorafenib (UNFINISHED drug), drug for further processing labeled by Bayer Ag. This tablet, film coated is formulated for 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 Ag on September 01, 2018. 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 Ag product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12527017109. 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 (5-4-1)
12527-0171-9
11-Digit CMS (5-4-2)
12527-0171-09

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