Kyzatrex Capsule, Liquid Filled
NDC Package 80603-103-22

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

Kyzatrex (testosterone undecanoate) capsules is a medication used in men who do not make enough of a natural substance called testosterone. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Marius Pharmaceuticals, this product is identified by NDC 80603-103 and is authorized under FDA application NDA213953.

Identification & Billing

NDC Package Code
80603-103-22
Package Description
120 CAPSULE, LIQUID FILLED in 1 BOTTLE
Product Code
80603-103
11-Digit Billing Format
80603010322
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
120 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Kyzatrex
Non-Proprietary Name
Testosterone Undecanoate
Substance Name
Testosterone Undecanoate
Dosage Form
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TESTOSTERONE UNDECANOATE 150 mg/1
Pharmacologic Class
Usage Information
This medication is used in men who do not make enough of a natural substance called testosterone. Testosterone belongs to a class of drugs known as androgens. Testosterone helps the body to develop and maintain male sexual characteristics (masculinity), such as a deep voice and body hair. It also helps to maintain muscle and prevent bone loss, and is necessary for natural sexual ability/desire. Testosterone may also be used in certain adolescent boys to cause puberty in those with delayed puberty. This product should not be used in women.
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Marius Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
NDA213953
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-27-2022
Listing Expiration
12-31-2026
Exclude Flag
N
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (80603-103). Click a package code to view its specific billing and regulatory data.

80603-103-11
90 CAPSULE, LIQUID FILLED 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 80603-103-22 identifies a specific commercial package of 120 capsule, liquid filled in 1 bottle of Kyzatrex, a human prescription drug labeled by Marius Pharmaceuticals. This product is billed for "EA" each discreet unit and contains an estimated amount of 120 billable units per package. This capsule, liquid filled is formulated for oral use and contains testosterone undecanoate 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 Marius Pharmaceuticals on July 27, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used in men who do not make enough of a natural substance called testosterone. Testosterone belongs to a class of drugs known as androgens. Testosterone helps the body to develop and maintain male sexual characteristics (masculinity), such as a deep voice and body hair. It also helps to maintain muscle and prevent bone loss, and is necessary for natural sexual ability/desire. Testosterone may also be used in certain adolescent boys to cause puberty in those with delayed puberty. This product should not be used in women.

How is this Marius Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80603010322. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 120 total billable units per package. 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)
80603-103-22
11-Digit CMS (5-4-2)
80603-0103-22

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