Inlyta Tablet, Film Coated
NDC Package 63539-044-01

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

Inlyta (axitinib) tablets is a medication used to treat kidney cancer. This formulation utilizes a tablet, film coated delivery system. Marketed by U.s. Pharmaceuticals, this product is identified by NDC 63539-044 and is authorized under FDA application NDA202324.

Identification & Billing

NDC Package Code
63539-044-01
Package Description
60 TABLET, FILM COATED in 1 BOTTLE
Product Code
63539-044
11-Digit Billing Format
63539004401
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Inlyta
Non-Proprietary Name
Axitinib
Substance Name
Axitinib
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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
AXITINIB 5 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat kidney cancer. Axitinib works by slowing or stopping the growth of cancer cells. It belongs to a class of drugs known as tyrosine kinase inhibitors.

Regulatory & Marketing

Labeler Name
U.s. Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
NDA202324
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-27-2012
Listing Expiration
12-31-2027
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 (63539-044). Click a package code to view its specific billing and regulatory data.

63539-044-02
30 TABLET, FILM COATED 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 63539-044-01 identifies a specific commercial package of 60 tablet, film coated in 1 bottle of Inlyta, a human prescription drug labeled by U.s. Pharmaceuticals. This tablet, film coated is formulated for oral use and contains axitinib 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 U.s. Pharmaceuticals on January 27, 2012. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat kidney cancer. Axitinib works by slowing or stopping the growth of cancer cells. It belongs to a class of drugs known as tyrosine kinase inhibitors.

How is this U.s. Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63539004401. 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)
63539-044-01
11-Digit CMS (5-4-2)
63539-0044-01

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