Lupron Depot Kit
NDC Package 0074-3473-55

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Lupron Depot (leuprolide acetate) kits is leuprolide is used to treat advanced prostate cancer in men. This formulation utilizes a kit delivery system. Marketed by Abbvie Inc., this product is identified by NDC 0074-3473 and is authorized under FDA application NDA020517.

Identification & Billing

NDC Package Code
0074-3473-55
Package Description
1 KIT in 1 CELLO PACK * 1.5 mL in 1 SYRINGE (0074-9945-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET
Product Code
0074-3473
11-Digit Billing Format
00074347355

Clinical Specifications

Proprietary Name
Lupron Depot
Non-Proprietary Name
Leuprolide Acetate
Dosage Form
Kit - A packaged collection of related material.
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
Abbvie Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA020517
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-22-1995
Listing Expiration
12-31-2027
Exclude Flag
N
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0074-3473). Click a package code to view its specific billing and regulatory data.

0074-3473-03
1 KIT in 1 CARTON * 1.5 mL in 1 SYRINGE (0074-9945-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET

* 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 0074-3473-55 identifies a specific commercial package of 1 kit in 1 cello pack * 1.5 ml in 1 syringe (0074-9945-01) * 1 swab in 1 packet (0074-0009-01) * 1.5 ml in 1 syringe * 1 swab in 1 packet of Lupron Depot, a human prescription drug labeled by Abbvie Inc.. This kit is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Abbvie Inc. on December 22, 1995. The current certification is valid through December 31, 2027.

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 Abbvie Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00074347355. 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 (4-4-2)
0074-3473-55
11-Digit CMS (5-4-2)
00074-3473-55

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