Leuprolide Acetate Injection, Powder, Lyophilized, For Suspension
NDC Package 11532-3680-1

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Leuprolide Acetate injection is leuprolide is used to treat advanced prostate cancer in men. This formulation utilizes a injection, powder, lyophilized, for suspension delivery system. Marketed by Takeda Pharmaceutical Company Ltd, this product is identified by NDC 11532-3680.

Identification & Billing

NDC Package Code
11532-3680-1
Package Description
200 SYRINGE in 1 DRUM / 1.5 mL in 1 SYRINGE
Product Code
11532-3680
11-Digit Billing Format
11532368001

Clinical Specifications

Proprietary Name
Leuprolide Acetate
Non-Proprietary Name
Leuprolide Acetate
Substance Name
Leuprolide Acetate
Dosage Form
Injection, Powder, Lyophilized, For Suspension - A liquid preparation, intended for parenteral use that contains solids suspended in a suitable fluid medium and conforms in all respects to the requirements for Sterile Suspensions; the medicinal agents intended for the suspension are prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures.
Active Ingredient(s)
LEUPROLIDE ACETATE 30 mg/1.5mL
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
Takeda Pharmaceutical Company Ltd
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
08-23-2010
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 11532-3680-1 identifies a specific commercial package of 200 syringe in 1 drum / 1.5 ml in 1 syringe of Leuprolide Acetate (UNFINISHED drug), drug for further processing labeled by Takeda Pharmaceutical Company Ltd. This injection, powder, lyophilized, for suspension is formulated for use and contains leuprolide acetate 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 Takeda Pharmaceutical Company Ltd on August 23, 2010. The current certification is valid through December 31, 2026.

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 Takeda Pharmaceutical Company Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11532368001. 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)
11532-3680-1
11-Digit CMS (5-4-2)
11532-3680-01

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