Testosterone
NDC Package 45802-116-65

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Testosterone is this medicated gel contains testosterone. Marketed by Perrigo New York Inc, this product is identified by NDC 45802-116 and is authorized under FDA application NDA203098.

Identification & Billing

NDC Package Code
45802-116-65
Package Description
30 POUCH in 1 CARTON / 2.5 g in 1 POUCH
Product Code
45802-116
11-Digit Billing Format
45802011665
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
2.5 GM

Clinical Specifications

Proprietary Name
Testosterone
Dosage Form
-
Usage Information
This medicated gel 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.

Regulatory & Marketing

Labeler Name
Perrigo New York Inc
FDA Application #
NDA203098
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-27-2014
End Marketing Date
03-01-2020
Listing Expiration
03-01-2020
Exclude Flag
D
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 (45802-116). Click a package code to view its specific billing and regulatory data.

45802-116-02
2 BOTTLE, PUMP in 1 CARTON / 88 g in 1 BOTTLE, PUMP
45802-116-39
30 POUCH in 1 CARTON / 5 g in 1 POUCH

* 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 45802-116-65 identifies a specific commercial package of 30 pouch in 1 carton / 2.5 g in 1 pouch of Testosterone, labeled by Perrigo New York Inc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Perrigo New York Inc on December 27, 2014. The current certification is valid through March 01, 2020.

What are the primary indications for this medication?

This medicated gel 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.

How is this Perrigo New York Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45802011665. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 2.5 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)
45802-116-65
11-Digit CMS (5-4-2)
45802-0116-65

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