Testim
NDC Package 35356-758-30

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 discontinued by the firm.

Testim is this medicated gel contains testosterone. Marketed by Lake Erie Medical Dba Quality Care Products Llc, this product is identified by NDC 35356-758 and is authorized under FDA application NDA021454.

Identification & Billing

NDC Package Code
35356-758-30
Package Description
30 TUBE in 1 CARTON / 5 g in 1 TUBE
Product Code
35356-758
11-Digit Billing Format
35356075830
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
5 GM

Clinical Specifications

Proprietary Name
Testim
Dosage Form
-
Usage Information
This medicated gel 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.

Regulatory & Marketing

Labeler Name
Lake Erie Medical Dba Quality Care Products Llc
FDA Application #
NDA021454
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-31-2002
End Marketing Date
01-01-2015
Listing Expiration
01-01-2015
Exclude Flag
D
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 35356-758-30 identifies a specific commercial package of 30 tube in 1 carton / 5 g in 1 tube of Testim, labeled by Lake Erie Medical Dba Quality Care Products Llc. This product is billed per "GM" gram and contains an estimated amount of 5 billable units per package. 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 Lake Erie Medical Dba Quality Care Products Llc on October 31, 2002. The current certification is valid through January 01, 2015.

What are the primary indications for this medication?

This medicated gel 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 Lake Erie Medical Dba Quality Care Products Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 35356075830. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 5 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 (5-3-2)
35356-758-30
11-Digit CMS (5-4-2)
35356-0758-30

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