Signifor Lar Kit
NDC Package 55292-142-01

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

Package Information

Signifor Lar (pasireotide) kits is pasireotide is used to treat a certain condition (acromegaly) that occurs when the body makes too much of a certain natural substance called growth hormone. This formulation utilizes a kit delivery system. Marketed by Recordati Rare Diseases, Inc., this product is identified by NDC 55292-142 and is authorized under FDA application NDA203255.

Identification & Billing

NDC Package Code
55292-142-01
Package Description
1 KIT in 1 KIT * 6 mL in 1 VIAL, SINGLE-USE (55292-137-01) * 2 mL in 1 SYRINGE
Product Code
55292-142
11-Digit Billing Format
55292014201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Signifor Lar
Non-Proprietary Name
Pasireotide
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Pasireotide is used to treat a certain condition (acromegaly) that occurs when the body makes too much of a certain natural substance called growth hormone. Treating acromegaly helps reduce the risk of serious problems such as diabetes and heart disease. Pasireotide works by decreasing the amount of growth hormone made in the body. Pasireotide is also used to treat a certain condition (Cushing's disease) when surgery has not been fully successful or cannot be used to correct the condition. Cushing's disease occurs when the body makes too much of a certain hormone called cortisol. Having too much cortisol in the body may lead to high blood pressure, high blood sugar, and other problems. Pasireotide works by decreasing the amount of cortisol made in the body.

Regulatory & Marketing

Labeler Name
Recordati Rare Diseases, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA203255
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-15-2014
Listing Expiration
12-31-2026
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 55292-142-01 identifies a specific commercial package of 1 kit in 1 kit * 6 ml in 1 vial, single-use (55292-137-01) * 2 ml in 1 syringe of Signifor Lar, a human prescription drug labeled by Recordati Rare Diseases, Inc.. This kit is formulated for 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 Recordati Rare Diseases, Inc. on December 15, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Pasireotide is used to treat a certain condition (acromegaly) that occurs when the body makes too much of a certain natural substance called growth hormone. Treating acromegaly helps reduce the risk of serious problems such as diabetes and heart disease. Pasireotide works by decreasing the amount of growth hormone made in the body. Pasireotide is also used to treat a certain condition (Cushing's disease) when surgery has not been fully successful or cannot be used to correct the condition. Cushing's disease occurs when the body makes too much of a certain hormone called cortisol. Having too much cortisol in the body may lead to high blood pressure, high blood sugar, and other problems. Pasireotide works by decreasing the amount of cortisol made in the body.

How is this Recordati Rare Diseases, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55292014201. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
55292-142-01
11-Digit CMS (5-4-2)
55292-0142-01

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