Trelstar
NDC Package 52544-092-76

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.

Trelstar is triptorelin is used to treat advanced prostate cancer in men. Marketed by Actavis Pharma, Inc., this product is identified by NDC 52544-092 and is authorized under FDA application NDA022437.

Identification & Billing

NDC Package Code
52544-092-76
Package Description
1 KIT in 1 CARTON * 2 mL in 1 VIAL, SINGLE-DOSE (52544-156-02) * 2 mL in 1 SYRINGE
Product Code
52544-092
11-Digit Billing Format
52544009276
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.

Clinical Specifications

Proprietary Name
Trelstar
Dosage Form
-
Usage Information
Triptorelin is used to treat advanced prostate cancer in men. It is not a cure. Most types of prostate cancer need the male hormone testosterone to grow and spread. Triptorelin works by reducing the amount of testosterone that the body makes. This effect helps slow or stop the growth of cancer cells and helps relieve symptoms such as painful/difficult urination. This medication is similar to a natural substance made by the body (luteinizing hormone releasing hormone-LHRH). Talk to your doctor about the risks and benefits of treatment.

Regulatory & Marketing

Labeler Name
Actavis Pharma, Inc.
FDA Application #
NDA022437
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-11-2010
End Marketing Date
10-31-2018
Listing Expiration
10-31-2018
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 52544-092-76 identifies a specific commercial package of 1 kit in 1 carton * 2 ml in 1 vial, single-dose (52544-156-02) * 2 ml in 1 syringe of Trelstar, 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 March 11, 2010. The current certification is valid through October 31, 2018.

What are the primary indications for this medication?

Triptorelin is used to treat advanced prostate cancer in men. It is not a cure. Most types of prostate cancer need the male hormone testosterone to grow and spread. Triptorelin works by reducing the amount of testosterone that the body makes. This effect helps slow or stop the growth of cancer cells and helps relieve symptoms such as painful/difficult urination. This medication is similar to a natural substance made by the body (luteinizing hormone releasing hormone-LHRH). Talk to your doctor about the risks and benefits of treatment.

How is this Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52544009276. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
52544-092-76
11-Digit CMS (5-4-2)
52544-0092-76

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