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  5. NDC Package Code: 80603-103-11 Kyzatrex

NDC Package 80603-103-11 Kyzatrex

Testosterone Undecanoate Capsule, Liquid Filled Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
80603-103-11
Package Description:
90 CAPSULE, LIQUID FILLED in 1 BOTTLE
Product Code:
80603-103
Proprietary Name:
Kyzatrex
Non-Proprietary Name:
Testosterone Undecanoate
Substance Name:
Testosterone Undecanoate
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.
11-Digit NDC Billing Format:
80603010311
NDC to RxNorm Crosswalk:
  • RxCUI: 2609597 - testosterone undecanoate 100 MG Oral Capsule
  • RxCUI: 2609603 - KYZATREX 100 MG Oral Capsule
  • RxCUI: 2609603 - testosterone undecanoate 100 MG Oral Capsule [Kyzatrex]
  • RxCUI: 2609603 - Kyzatrex 100 MG Oral Capsule
  • RxCUI: 2609605 - testosterone undecanoate 150 MG Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Marius Pharmaceuticals
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • TESTOSTERONE UNDECANOATE 150 mg/1
    • Pharmacologic Class(es):
  • Androgen Receptor Agonists - [MoA] (Mechanism of Action)
  • Androgen - [EPC] (Established Pharmacologic Class)
  • Androstanes - [CS]
    • DEA Schedule:
    Schedule III (CIII) Substances
    Sample Package:
    No
    FDA Application Number:
    NDA213953
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    07-27-2022
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    80603-103-22120 CAPSULE, LIQUID FILLED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 80603-103-11?

    The NDC Packaged Code 80603-103-11 is assigned to a package of 90 capsule, liquid filled in 1 bottle of Kyzatrex, a human prescription drug labeled by Marius Pharmaceuticals. The product's dosage form is capsule, liquid filled and is administered via oral form.

    Is NDC 80603-103 included in the NDC Directory?

    Yes, Kyzatrex with product code 80603-103 is active and included in the NDC Directory. The product was first marketed by Marius Pharmaceuticals on July 27, 2022 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 80603-103-11?

    The 11-digit format is 80603010311. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-280603-103-115-4-280603-0103-11