Leuprolide Acetate Kit
NDC Package 72843-591-99

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

Package Information

Leuprolide Acetate kits is leuprolide is used to treat advanced prostate cancer in men. This formulation utilizes a kit delivery system. Marketed by Ubi Pharma Inc., this product is identified by NDC 72843-591 and is authorized under FDA application ANDA217957.

Identification & Billing

NDC Package Code
72843-591-99
Package Description
1 KIT in 1 CARTON * 1 VIAL, MULTI-DOSE in 1 CARTON (72843-590-01) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET
Product Code
72843-591
11-Digit Billing Format
72843059199
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Leuprolide Acetate
Non-Proprietary Name
Leuprolide Acetate
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
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
Ubi Pharma Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA217957
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-25-2024
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 72843-591-99 identifies a specific commercial package of 1 kit in 1 carton * 1 vial, multi-dose in 1 carton (72843-590-01) / 2.8 ml in 1 vial, multi-dose * 1 ml in 1 packet of Leuprolide Acetate, a human prescription drug labeled by Ubi Pharma Inc.. This kit is formulated for subcutaneous 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 Ubi Pharma Inc. on October 25, 2024. 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. 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 Ubi Pharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72843059199. 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)
72843-591-99
11-Digit CMS (5-4-2)
72843-0591-99

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