Testosterone Gel
NDC Package 0591-2921-02

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

Package Information

Testosterone gel is this medicated gel contains testosterone. This formulation utilizes a gel delivery system. Marketed by Actavis Pharma, Inc., this product is identified by NDC 0591-2921 and is authorized under FDA application ANDA076737.

Identification & Billing

NDC Package Code
0591-2921-02
Package Description
2 BOTTLE, PUMP in 1 CARTON / 75 g in 1 BOTTLE, PUMP (0591-2921-18)
Product Code
0591-2921
11-Digit Billing Format
00591292102
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
75 GM
RxNorm Crosswalk
  • RxCUI: 1596780 - testosterone 1 % (12.5 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUAT
  • RxCUI: 1596780 - 60 ACTUAT testosterone 12.5 MG/ACTUAT Topical Gel
  • RxCUI: 1596780 - testosterone 12.5 MG/ACTUAT Transdermal Gel Pump, 60 ACTUAT
  • RxCUI: 1597123 - testosterone 1 % (25 MG / 2.5 GM) Transdermal Gel
  • RxCUI: 1597123 - 2500 MG testosterone 0.01 MG/MG Topical Gel

Clinical Specifications

Proprietary Name
Testosterone
Non-Proprietary Name
Testosterone
Substance Name
Testosterone
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
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 10 mg/g
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
Actavis Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA076737
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-14-2015
Listing Expiration
12-31-2027
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 0591-2921-02 identifies a specific commercial package of 2 bottle, pump in 1 carton / 75 g in 1 bottle, pump (0591-2921-18) of Testosterone, a human prescription drug labeled by Actavis Pharma, Inc.. This gel 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 Actavis Pharma, Inc. on December 14, 2015. The current certification is valid through December 31, 2027.

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 Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591292102. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 75 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 (4-4-2)
0591-2921-02
11-Digit CMS (5-4-2)
00591-2921-02

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