Testosterone Undecanoate Powder
NDC Package 70492-005-01

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 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.

Testosterone Undecanoate powders is a medication used in men who do not make enough of a natural substance called testosterone. This formulation utilizes a powder delivery system. Marketed by Hubei Zhuxi Humanwell Pharmaceutical Co., Ltd., this product is identified by NDC 70492-005.

Identification & Billing

NDC Package Code
70492-005-01
Package Description
1 kg in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK
Product Code
70492-005
11-Digit Billing Format
70492000501

Clinical Specifications

Proprietary Name
Testosterone Undecanoate
Non-Proprietary Name
Testosterone Undecanoate
Substance Name
Testosterone Undecanoate
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 UNDECANOATE 1 kg/kg
Usage Information
This medication is used in men who do not make enough of a natural substance called testosterone. Testosterone belongs to a class of drugs known as androgens. Testosterone helps the body to develop and maintain 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. Testosterone may also be used in certain adolescent boys to cause puberty in those with delayed puberty. This product should not be used in women.
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Hubei Zhuxi Humanwell Pharmaceutical Co., Ltd.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
05-13-2024
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70492-005). Click a package code to view its specific billing and regulatory data.

70492-005-00
.5 kg in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK
70492-005-05
5 kg in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK
70492-005-25
25 kg in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK

* 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 70492-005-01 identifies a specific commercial package of 1 kg in 1 container, flexible intermediate bulk of Testosterone Undecanoate (UNFINISHED drug), a bulk ingredient labeled by Hubei Zhuxi Humanwell Pharmaceutical Co., Ltd.. This powder is formulated for use and contains testosterone undecanoate 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 Hubei Zhuxi Humanwell Pharmaceutical Co., Ltd. on May 13, 2024. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used in men who do not make enough of a natural substance called testosterone. Testosterone belongs to a class of drugs known as androgens. Testosterone helps the body to develop and maintain 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. Testosterone may also be used in certain adolescent boys to cause puberty in those with delayed puberty. This product should not be used in women.

How is this Hubei Zhuxi Humanwell Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70492000501. 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)
70492-005-01
11-Digit CMS (5-4-2)
70492-0005-01

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