Testosterone Powder
NDC Package 38779-0163-5

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. 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 powders is this medicated patch contains testosterone. This formulation utilizes a powder delivery system. Marketed by Medisca Inc., this product is identified by NDC 38779-0163.

Identification & Billing

NDC Package Code
38779-0163-5
Package Description
100 g in 1 VIAL
Product Code
38779-0163
11-Digit Billing Format
38779016305
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
100 GM

Clinical Specifications

Proprietary Name
Testosterone
Non-Proprietary Name
Testosterone
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 g/g
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
Medisca Inc.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
04-24-2012
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J3490
Source: PDAC
UNCLASSIFIED DRUGS
HCPCS Dosage 1 GM
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 (38779-0163). Click a package code to view its specific billing and regulatory data.

38779-0163-1
10 g in 1 JAR
38779-0163-3
5 g in 1 VIAL
38779-0163-4
25 g in 1 VIAL
38779-0163-7
20000 g in 1 DRUM
38779-0163-8
500 g in 1 JAR
38779-0163-9
1000 g in 1 JAR

* 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 38779-0163-5 identifies a specific commercial package of 100 g in 1 vial of Testosterone (UNFINISHED drug), a bulk ingredient labeled by Medisca Inc.. This product is billed per "GM" gram and contains an estimated amount of 100 billable units per package. 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 Medisca Inc. on April 24, 2012. 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 Medisca Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 38779016305. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 100 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 (5-4-1)
38779-0163-5
11-Digit CMS (5-4-2)
38779-0163-05

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