Lupron Depot
NDC Package 54868-2825-0

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.

Lupron Depot is leuprolide is used to treat advanced prostate cancer in men. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-2825 and is authorized under FDA application NDA020011.

Identification & Billing

NDC Package Code
54868-2825-0
Package Description
1 KIT in 1 CARTON * 1 SWAB in 1 PACKET * 1 mL in 1 SYRINGE
Product Code
54868-2825
11-Digit Billing Format
54868282500

Clinical Specifications

Proprietary Name
Lupron Depot
Dosage Form
-
Usage Information
Leuprolide 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. Leuprolide works by reducing the amount of testosterone that the body makes. This helps slow or stop the growth of cancer cells and helps relieve symptoms such as painful/difficult urination. Talk to your doctor about the risks and benefits of treatment.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA020011
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-22-1990
End Marketing Date
12-31-2010
Listing Expiration
12-31-2010
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 54868-2825-0 identifies a specific commercial package of 1 kit in 1 carton * 1 swab in 1 packet * 1 ml in 1 syringe of Lupron Depot, labeled by Physicians Total Care, 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 Physicians Total Care, Inc. on October 22, 1990. The current certification is valid through December 31, 2010.

What are the primary indications for this medication?

Leuprolide 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. Leuprolide works by reducing the amount of testosterone that the body makes. This helps slow or stop the growth of cancer cells and helps relieve symptoms such as painful/difficult urination. Talk to your doctor about the risks and benefits of treatment.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868282500. 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)
54868-2825-0
11-Digit CMS (5-4-2)
54868-2825-00

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