Testosterone Enanthate Injection, Solution
NDC Package 49803-005-01

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.

Testosterone Enanthate injection is a medication used in men who do not make enough of a natural substance called testosterone. This formulation utilizes a injection, solution delivery system. Marketed by Steroid S.p.a., this product is identified by NDC 49803-005.

Identification & Billing

NDC Package Code
49803-005-01
Package Description
2 BAG in 1 CONTAINER / 25000 g in 1 BAG
Product Code
49803-005
11-Digit Billing Format
49803000501

Clinical Specifications

Proprietary Name
Testosterone Enanthate
Non-Proprietary Name
Testosterone Enanthate
Substance Name
Testosterone Enanthate
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Active Ingredient(s)
TESTOSTERONE ENANTHATE 25000 g/25000g
Usage Information
This medication is used in men who do not make enough of a natural substance called testosterone. In males, testosterone is responsible for many normal functions, including growth and development of the genitals, muscles, and bones. It also helps cause normal sexual development (puberty) in boys. Testosterone belongs to a class of drugs known as androgens. It works by affecting many body systems so that the body can develop and function normally. Testosterone may also be used in certain adolescent boys to cause puberty in those with delayed puberty. It may also be used to treat certain types of breast cancer in women.
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Steroid S.p.a.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
04-17-2018
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 49803-005-01 identifies a specific commercial package of 2 bag in 1 container / 25000 g in 1 bag of Testosterone Enanthate (UNFINISHED drug), a bulk ingredient labeled by Steroid S.p.a.. This injection, solution is formulated for use and contains testosterone enanthate 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 Steroid S.p.a. on April 17, 2018. The current certification is valid through December 31, 2026.

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. In males, testosterone is responsible for many normal functions, including growth and development of the genitals, muscles, and bones. It also helps cause normal sexual development (puberty) in boys. Testosterone belongs to a class of drugs known as androgens. It works by affecting many body systems so that the body can develop and function normally. Testosterone may also be used in certain adolescent boys to cause puberty in those with delayed puberty. It may also be used to treat certain types of breast cancer in women.

How is this Steroid S.p.a. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49803000501. 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)
49803-005-01
11-Digit CMS (5-4-2)
49803-0005-01

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