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  5. NDC Package Code: 21922-019-02 Testosterone Gel, 1%

NDC Package 21922-019-02 Testosterone Gel, 1%

Gel Transdermal - 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:
21922-019-02
Package Description:
30 PACKET in 1 CARTON / 5 g in 1 PACKET
Product Code:
21922-019
Proprietary Name:
Testosterone Gel, 1%
Non-Proprietary Name:
Testosterone Gel, 1%
Substance Name:
Testosterone
Usage Information:
This medicated patch contains testosterone. It is used for hormone replacement in men who are not able to produce enough testosterone (for example, due to hypogonadism). This medication is absorbed through the skin, enters your bloodstream, and helps your body reach normal testosterone levels. Testosterone helps the body to develop and maintain the 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. This drug should not be used by women.
11-Digit NDC Billing Format:
21922001902
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
5 GM
NDC to RxNorm Crosswalk:
  • RxCUI: 1597129 - testosterone 1 % (50 MG / 5 GM) Transdermal Gel
  • RxCUI: 1597129 - 5000 MG testosterone 0.01 MG/MG Topical Gel
  • RxCUI: 1597129 - testosterone 50 MG Transdermal Gel, 5 GM
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Encube Ethicals Private Limited
    Dosage Form:
    Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
    Administration Route(s):
  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
    • Active Ingredient(s):
  • TESTOSTERONE 10 mg/g
    • 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:
    ANDA212984
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-14-2024
    Listing Expiration Date:
    12-31-2025
    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
    21922-019-472 CONTAINER in 1 CARTON / 75 g in 1 CONTAINER

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 21922-019-02?

    The NDC Packaged Code 21922-019-02 is assigned to a package of 30 packet in 1 carton / 5 g in 1 packet of Testosterone Gel, 1%, a human prescription drug labeled by Encube Ethicals Private Limited. The product's dosage form is gel and is administered via transdermal form.

    Is NDC 21922-019 included in the NDC Directory?

    Yes, Testosterone Gel, 1% with product code 21922-019 is active and included in the NDC Directory. The product was first marketed by Encube Ethicals Private Limited on February 14, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 21922-019-02?

    The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight. The calculated billable units for this package is 5.

    What is the 11-digit format for NDC 21922-019-02?

    The 11-digit format is 21922001902. 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
    5-3-221922-019-025-4-221922-0019-02