Natesto
NDC Package 69654-239-01

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Natesto is a medication used by men who do not make enough of a natural substance called testosterone (hypogonadism). Marketed by Aytu Bioscience, Inc., this product is identified by NDC 69654-239 and is authorized under FDA application NDA205488.

Identification & Billing

NDC Package Code
69654-239-01
Package Description
1 BOTTLE, PUMP in 1 CARTON / 60 GEL in 1 BOTTLE, PUMP
Product Code
69654-239
11-Digit Billing Format
69654023901
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Natesto
Dosage Form
-
Usage Information
This medication is used by men who do not make enough of a natural substance called testosterone (hypogonadism). 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. This drug should not be used by women.

Regulatory & Marketing

Labeler Name
Aytu Bioscience, Inc.
FDA Application #
NDA205488
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-01-2017
Listing Expiration
12-31-2020
Exclude Flag
I
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 69654-239-01 identifies a specific commercial package of 1 bottle, pump in 1 carton / 60 gel in 1 bottle, pump of Natesto, labeled by Aytu Bioscience, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Aytu Bioscience, Inc. on September 01, 2017. The current certification is valid through December 31, 2020.

What are the primary indications for this medication?

This medication is used by men who do not make enough of a natural substance called testosterone (hypogonadism). 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. This drug should not be used by women.

How is this Aytu Bioscience, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69654023901. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. 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)
69654-239-01
11-Digit CMS (5-4-2)
69654-0239-01

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