Testosterone Solution
NDC Package 45802-610-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Testosterone solution is this medicated gel contains testosterone. This formulation utilizes a solution delivery system. Marketed by Padagis Israel Pharmaceuticals Ltd, this product is identified by NDC 45802-610 and is authorized under FDA application ANDA204255.

Identification & Billing

NDC Package Code
45802-610-01
Package Description
1 BOTTLE, PUMP in 1 CARTON / 110 mL in 1 BOTTLE, PUMP
Product Code
45802-610
11-Digit Billing Format
45802061001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1599949 - testosterone 2 % (30 MG/ACTUAT) Topical Solution, 60 ACTUAT
  • RxCUI: 1599949 - 60 ACTUAT testosterone 30 MG/ACTUAT Topical Solution
  • RxCUI: 1599949 - 60 ACTUAT testosterone 30 MG/1.5 ML ACTUAT Topical Solution
  • RxCUI: 1599949 - testosterone (as testosterone propionate) 2 % Topical Solution

Clinical Specifications

Proprietary Name
Testosterone
Non-Proprietary Name
Testosterone
Substance Name
Testosterone
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
TESTOSTERONE 30 mg/1.5mL
Pharmacologic Class
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.
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Padagis Israel Pharmaceuticals Ltd
Product Type
Human Prescription Drug
FDA Application #
ANDA204255
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-28-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 45802-610-01 identifies a specific commercial package of 1 bottle, pump in 1 carton / 110 ml in 1 bottle, pump of Testosterone, a human prescription drug labeled by Padagis Israel Pharmaceuticals Ltd. This solution is formulated for topical use and contains testosterone 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 Padagis Israel Pharmaceuticals Ltd on June 28, 2017. The current certification is valid through December 31, 2026.

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 Padagis Israel Pharmaceuticals Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45802061001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
45802-610-01
11-Digit CMS (5-4-2)
45802-0610-01

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