Lupron Depot-ped
NDC Package 52125-736-01

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-ped is leuprolide is used to stop early puberty (precocious puberty) in children. Marketed by Remedyrepack Inc., this product is identified by NDC 52125-736 and is authorized under FDA application NDA020263.

Identification & Billing

NDC Package Code
52125-736-01
Package Description
1 KIT in 1 KIT * 1 mL in 1 SYRINGE * 1 SWAB in 1 CARTON
Product Code
52125-736
11-Digit Billing Format
52125073601

Clinical Specifications

Proprietary Name
Lupron Depot-ped
Dosage Form
-
Usage Information
Leuprolide is 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
Remedyrepack Inc.
FDA Application #
NDA020263
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-28-2015
End Marketing Date
07-28-2016
Listing Expiration
07-28-2016
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 52125-736-01 identifies a specific commercial package of 1 kit in 1 kit * 1 ml in 1 syringe * 1 swab in 1 carton of Lupron Depot-ped, labeled by Remedyrepack 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 Remedyrepack Inc. on July 28, 2015. The current certification is valid through July 28, 2016.

What are the primary indications for this medication?

Leuprolide is 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 Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52125073601. 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)
52125-736-01
11-Digit CMS (5-4-2)
52125-0736-01

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