Natesto Gel, Metered
NDC Package 42667-5511-1

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

Package Information

Natesto (testosterone) gel is a medication used by men who do not make enough of a natural substance called testosterone (hypogonadism). This formulation utilizes a gel, metered delivery system. Marketed by Acerus Pharmaceuticals Corporation, this product is identified by NDC 42667-5511 and is authorized under FDA application NDA205488.

Identification & Billing

NDC Package Code
42667-5511-1
Package Description
1 APPLICATOR in 1 BOX / 11 g in 1 APPLICATOR
Product Code
42667-5511
11-Digit Billing Format
42667551101
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
11 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Natesto Nasal Gel
Non-Proprietary Name
Testosterone
Substance Name
Testosterone
Dosage Form
Gel, Metered - A gel preparation, with metered dose valves, which allow for the delivery of a uniform quantity of gel upon each activation.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
TESTOSTERONE 5.5 mg/.122g
Pharmacologic Class
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.
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Acerus Pharmaceuticals Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA205488
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-08-2020
Listing Expiration
12-31-2026
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 42667-5511-1 identifies a specific commercial package of 1 applicator in 1 box / 11 g in 1 applicator of Natesto Nasal Gel, a human prescription drug labeled by Acerus Pharmaceuticals Corporation. This gel, metered is formulated for nasal 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 Acerus Pharmaceuticals Corporation on May 08, 2020. The current certification is valid through December 31, 2026.

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 Acerus Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42667551101. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 11 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)
42667-5511-1
11-Digit CMS (5-4-2)
42667-5511-01

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