Androderm
NDC Package 52544-077-30

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.

Androderm is this medicated patch contains testosterone. Marketed by Actavis Pharma, Inc., this product is identified by NDC 52544-077 and is authorized under FDA application NDA020489.

Identification & Billing

NDC Package Code
52544-077-30
Package Description
30 POUCH in 1 CARTON / 1 PATCH in 1 POUCH / 1 d in 1 PATCH
Product Code
52544-077
11-Digit Billing Format
52544007730
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Androderm
Dosage Form
-
Usage Information
This medicated patch 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
Actavis Pharma, Inc.
FDA Application #
NDA020489
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-29-1995
End Marketing Date
01-31-2020
Listing Expiration
01-31-2020
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 52544-077-30 identifies a specific commercial package of 30 pouch in 1 carton / 1 patch in 1 pouch / 1 d in 1 patch of Androderm, labeled by Actavis Pharma, 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 Actavis Pharma, Inc. on September 29, 1995. The current certification is valid through January 31, 2020.

What are the primary indications for this medication?

This medicated patch 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 Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52544007730. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
52544-077-30
11-Digit CMS (5-4-2)
52544-0077-30

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