Leuprolide Acetate
NDC Package 49884-368-26

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.

Leuprolide Acetate is leuprolide is used to treat advanced prostate cancer in men. Marketed by Genzyme Corporation, this product is identified by NDC 49884-368 and is authorized under FDA application ANDA075721.

Identification & Billing

NDC Package Code
49884-368-26
Package Description
1 KIT in 1 CARTON * 1 SWAB in 1 PACKET * 1 VIAL, MULTI-DOSE in 1 KIT / 2.8 mL in 1 VIAL, MULTI-DOSE
Product Code
49884-368
11-Digit Billing Format
49884036826

Clinical Specifications

Proprietary Name
Leuprolide Acetate
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. Leuprolide is also used to stop early puberty (precocious puberty) in children. It helps to delay sexual development (such as growth of the breasts/testicles) and the start of menstrual periods. It also helps slow down early bone growth to increase the likelihood of reaching normal adult height. Leuprolide works by decreasing the amount of sex hormones that a child's body makes (estrogen in girls, testosterone in boys).

Regulatory & Marketing

Labeler Name
Genzyme Corporation
FDA Application #
ANDA075721
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-29-2001
End Marketing Date
03-31-2010
Listing Expiration
03-31-2010
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 49884-368-26 identifies a specific commercial package of 1 kit in 1 carton * 1 swab in 1 packet * 1 vial, multi-dose in 1 kit / 2.8 ml in 1 vial, multi-dose of Leuprolide Acetate, labeled by Genzyme Corporation. 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 Genzyme Corporation on November 29, 2001. The current certification is valid through March 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. Leuprolide is also used to stop early puberty (precocious puberty) in children. It helps to delay sexual development (such as growth of the breasts/testicles) and the start of menstrual periods. It also helps slow down early bone growth to increase the likelihood of reaching normal adult height. Leuprolide works by decreasing the amount of sex hormones that a child's body makes (estrogen in girls, testosterone in boys).

How is this Genzyme Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49884036826. 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)
49884-368-26
11-Digit CMS (5-4-2)
49884-0368-26

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