Cabometyx Tablet
NDC Package 42388-024-57

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

Cabometyx (cabozantinib) tablets is a medication used to treat various types of cancer (including kidney, thyroid, liver cancer). This formulation utilizes a tablet delivery system. Marketed by Exelixis, Inc., this product is identified by NDC 42388-024 and is authorized under FDA application NDA208692.

Identification & Billing

NDC Package Code
42388-024-57
Package Description
1 BOTTLE in 1 CARTON / 15 TABLET in 1 BOTTLE
Product Code
42388-024
11-Digit Billing Format
42388002457
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cabometyx
Non-Proprietary Name
Cabozantinib
Substance Name
Cabozantinib S-malate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CABOZANTINIB S-MALATE 20 mg/1
Pharmacologic Class
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.
Product Type
Human Prescription Drug
FDA Application #
NDA208692
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-25-2016
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

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 (42388-024). Click a package code to view its specific billing and regulatory data.

42388-024-26
30 TABLET in 1 BOTTLE
42388-024-37
15 TABLET in 1 BOTTLE
42388-024-46
1 BOTTLE in 1 CARTON / 30 TABLET in 1 BOTTLE

* 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 42388-024-57 identifies a specific commercial package of 1 bottle in 1 carton / 15 tablet in 1 bottle of Cabometyx, a human prescription drug labeled by Exelixis, Inc.. This tablet is formulated for oral use and contains cabozantinib s-malate 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 Exelixis, Inc. on April 25, 2016. The current certification is valid through December 31, 2026.

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: 42388002457. 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)
42388-024-57
11-Digit CMS (5-4-2)
42388-0024-57

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