Tetsoteron Micronized Powder
NDC Package 12866-1175-0

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Tetsoteron Micronized powders is this medicated patch contains testosterone. This formulation utilizes a powder delivery system. Marketed by Bayer Ag, this product is identified by NDC 12866-1175.

Identification & Billing

NDC Package Code
12866-1175-0
Package Description
5 kg in 1 CONTAINER
Product Code
12866-1175
11-Digit Billing Format
12866117500

Clinical Specifications

Proprietary Name
Tetsoteron Micronized
Non-Proprietary Name
Tetsoteron Micronized
Substance Name
Testosterone
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
TESTOSTERONE 1 kg/kg
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.
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Bayer Ag
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
05-15-2017
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 12866-1175-0 identifies a specific commercial package of 5 kg in 1 container of Tetsoteron Micronized (UNFINISHED drug), a bulk ingredient labeled by Bayer Ag. This powder is formulated for 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 Bayer Ag on May 15, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Bayer Ag product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12866117500. 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 (5-4-1)
12866-1175-0
11-Digit CMS (5-4-2)
12866-1175-00

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