Triptorelin Pamoate Injection, Powder, For Suspension
NDC Package 62788-288-01

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 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.

Triptorelin Pamoate injection is triptorelin is used to treat advanced prostate cancer in men. This formulation utilizes a injection, powder, for suspension delivery system. Marketed by Debiopharm Research & Manufacturing Sa, this product is identified by NDC 62788-288.

Identification & Billing

NDC Package Code
62788-288-01
Package Description
2 mL in 1 VIAL
Product Code
62788-288
11-Digit Billing Format
62788028801

Clinical Specifications

Proprietary Name
Triptorelin Pamoate
Non-Proprietary Name
Triptorelin Pamoate
Substance Name
Triptorelin Pamoate
Dosage Form
Injection, Powder, For Suspension - A sterile preparation intended for reconstitution to form a suspension for parenteral use.
Active Ingredient(s)
TRIPTORELIN PAMOATE 11.25 mg/2mL
Usage Information
Triptorelin 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. Triptorelin works by reducing the amount of testosterone that the body makes. This effect helps slow or stop the growth of cancer cells and helps relieve symptoms such as painful/difficult urination. This medication is similar to a natural substance made by the body (luteinizing hormone releasing hormone-LHRH). Talk to your doctor about the risks and benefits of treatment.

Regulatory & Marketing

Labeler Name
Debiopharm Research & Manufacturing Sa
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
06-29-2001
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 62788-288-01 identifies a specific commercial package of 2 ml in 1 vial of Triptorelin Pamoate (UNFINISHED drug), drug for further processing labeled by Debiopharm Research & Manufacturing Sa. This injection, powder, for suspension is formulated for use and contains triptorelin pamoate 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 Debiopharm Research & Manufacturing Sa on June 29, 2001. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Triptorelin 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. Triptorelin works by reducing the amount of testosterone that the body makes. This effect helps slow or stop the growth of cancer cells and helps relieve symptoms such as painful/difficult urination. This medication is similar to a natural substance made by the body (luteinizing hormone releasing hormone-LHRH). Talk to your doctor about the risks and benefits of treatment.

How is this Debiopharm Research & Manufacturing Sa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62788028801. 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)
62788-288-01
11-Digit CMS (5-4-2)
62788-0288-01

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