Aveed Injection
NDC Package 67979-511-43

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

Package Information

Aveed (testosterone undecanoate) injection is a medication used in men who do not make enough of a natural substance called testosterone. This formulation utilizes a injection delivery system. Marketed by Endo Usa, Inc., this product is identified by NDC 67979-511 and is authorized under FDA application NDA022219.

Identification & Billing

NDC Package Code
67979-511-43
Package Description
1 VIAL, SINGLE-USE in 1 CARTON / 3 mL in 1 VIAL, SINGLE-USE
Product Code
67979-511
11-Digit Billing Format
67979051143
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Aveed
Non-Proprietary Name
Testosterone Undecanoate
Substance Name
Testosterone Undecanoate
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
TESTOSTERONE UNDECANOATE 250 mg/mL
Pharmacologic Class
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
Endo Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA022219
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-05-2014
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 67979-511-43 identifies a specific commercial package of 1 vial, single-use in 1 carton / 3 ml in 1 vial, single-use of Aveed, a human prescription drug labeled by Endo Usa, Inc.. This injection is formulated for intramuscular 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 Endo Usa, Inc. on March 05, 2014. 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 Endo Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67979051143. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
67979-511-43
11-Digit CMS (5-4-2)
67979-0511-43

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