Regorafenib Monohydrate Powder
NDC Package 12527-0181-1

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 Monohydrate powders is regorafenib is used to treat cancer of the colon and rectum. This formulation utilizes a powder delivery system. Marketed by Bayer Ag, this product is identified by NDC 12527-0181.

Identification & Billing

NDC Package Code
12527-0181-1
Package Description
50 kg in 1 DRUM
Product Code
12527-0181
11-Digit Billing Format
12527018101

Clinical Specifications

Proprietary Name
Regorafenib Monohydrate
Non-Proprietary Name
Regorafenib Monohydrate
Substance Name
Regorafenib
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
REGORAFENIB 1 kg/kg
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
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
04-24-2024
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 12527-0181-1 identifies a specific commercial package of 50 kg in 1 drum of Regorafenib Monohydrate (UNFINISHED drug), a bulk ingredient labeled by Bayer Ag. This powder 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 April 24, 2024. 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: 12527018101. 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)
12527-0181-1
11-Digit CMS (5-4-2)
12527-0181-01

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