Cometriq
NDC Package 42388-014-25

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Cometriq is a medication used to treat various types of cancer (including kidney, thyroid, liver cancer). Marketed by Exelixis, Inc., this product is identified by NDC 42388-014 and is authorized under FDA application NDA203756.

Identification & Billing

NDC Package Code
42388-014-25
Package Description
60 CAPSULE in 1 BOTTLE
Product Code
42388-014
11-Digit Billing Format
42388001425

Clinical Specifications

Proprietary Name
Cometriq
Dosage Form
-
Usage Information
This medication is used to treat various types of cancer (including kidney, thyroid, liver cancer). Cabozantinib belongs to a class of drugs known as tyrosine kinase inhibitors. It works by slowing or stopping the growth of cancer cells.

Regulatory & Marketing

Labeler Name
Exelixis, Inc.
FDA Application #
NDA203756
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-29-2012
End Marketing Date
05-31-2016
Listing Expiration
05-31-2016
Exclude Flag
D
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42388-014-25 identifies a specific commercial package of 60 capsule in 1 bottle of Cometriq, labeled by Exelixis, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Exelixis, Inc. on November 29, 2012. The current certification is valid through May 31, 2016.

What are the primary indications for this medication?

This medication is used to treat various types of cancer (including kidney, thyroid, liver cancer). Cabozantinib belongs to a class of drugs known as tyrosine kinase inhibitors. It works by slowing or stopping the growth of cancer cells.

How is this Exelixis, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42388001425. 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)
42388-014-25
11-Digit CMS (5-4-2)
42388-0014-25

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