Somatuline Depot
NDC Package 15054-0060-1

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Somatuline Depot is a medication a long-acting form of lanreotide. Marketed by Ipsen Biopharmaceuticals, Inc., this product is identified by NDC 15054-0060 and is authorized under FDA application NDA022074.

Identification & Billing

NDC Package Code
15054-0060-1
Package Description
1 POUCH in 1 CARTON / 1 SYRINGE in 1 POUCH / .2 mL in 1 SYRINGE
Product Code
15054-0060
11-Digit Billing Format
15054006001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Somatuline Depot
Dosage Form
-
Usage Information
This medication is a long-acting form of lanreotide. Lanreotide is used to treat a condition called acromegaly that occurs when the body makes too much of a certain natural substance called growth hormone. It is used when surgery or radiation treatment have not been fully successful or cannot be used. Treating acromegaly helps reduce the risk of serious problems such as diabetes and heart disease. Lanreotide works by decreasing the amount of growth hormone to normal levels. This drug is not a cure for acromegaly. It is used for the long-term treatment of this condition. This medication is also used to treat certain cancer or tumors of the stomach, intestines, or pancreas. It may help to slow down the growth of these tumors. Lanreotide is also used to treat carcinoid syndrome. It may help reduce the need to use another medication to treat diarrhea or flushing caused by carcinoid syndrome.

Regulatory & Marketing

Labeler Name
Ipsen Biopharmaceuticals, Inc.
FDA Application #
NDA022074
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-14-2007
End Marketing Date
08-31-2016
Listing Expiration
08-31-2016
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 15054-0060-1 identifies a specific commercial package of 1 pouch in 1 carton / 1 syringe in 1 pouch / .2 ml in 1 syringe of Somatuline Depot, labeled by Ipsen Biopharmaceuticals, 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 Ipsen Biopharmaceuticals, Inc. on November 14, 2007. The current certification is valid through August 31, 2016.

What are the primary indications for this medication?

This medication is a long-acting form of lanreotide. Lanreotide is used to treat a condition called acromegaly that occurs when the body makes too much of a certain natural substance called growth hormone. It is used when surgery or radiation treatment have not been fully successful or cannot be used. Treating acromegaly helps reduce the risk of serious problems such as diabetes and heart disease. Lanreotide works by decreasing the amount of growth hormone to normal levels. This drug is not a cure for acromegaly. It is used for the long-term treatment of this condition. This medication is also used to treat certain cancer or tumors of the stomach, intestines, or pancreas. It may help to slow down the growth of these tumors. Lanreotide is also used to treat carcinoid syndrome. It may help reduce the need to use another medication to treat diarrhea or flushing caused by carcinoid syndrome.

How is this Ipsen Biopharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 15054006001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
15054-0060-1
11-Digit CMS (5-4-2)
15054-0060-01

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