Encorafenib Capsule
NDC Package 85247-0002-1

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.

Encorafenib capsules is encorafenib is used to treat certain types of cancer (such as melanoma skin cancer, cancer in the colon or rectum). This formulation utilizes a capsule delivery system. Marketed by Ardena Us, Llc, this product is identified by NDC 85247-0002.

Identification & Billing

NDC Package Code
85247-0002-1
Package Description
1 BAG in 1 CONTAINER / 7000 CAPSULE in 1 BAG
Product Code
85247-0002
11-Digit Billing Format
85247000201

Clinical Specifications

Proprietary Name
Encorafenib
Non-Proprietary Name
Encorafenib
Substance Name
Encorafenib
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Active Ingredient(s)
ENCORAFENIB 50 mg/1
Usage Information
Encorafenib is used to treat certain types of cancer (such as melanoma skin cancer, cancer in the colon or rectum). Encorafenib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of cancer cells.

Regulatory & Marketing

Labeler Name
Ardena Us, Llc
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
02-04-2025
Listing Expiration
12-31-2026
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 85247-0002-1 identifies a specific commercial package of 1 bag in 1 container / 7000 capsule in 1 bag of Encorafenib (UNFINISHED drug), drug for further processing labeled by Ardena Us, Llc. This capsule is formulated for use and contains encorafenib 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 Ardena Us, Llc on February 04, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Encorafenib is used to treat certain types of cancer (such as melanoma skin cancer, cancer in the colon or rectum). Encorafenib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of cancer cells.

How is this Ardena Us, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85247000201. 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)
85247-0002-1
11-Digit CMS (5-4-2)
85247-0002-01

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