Signifor Lar
NDC Package 0078-0643-81

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.

Signifor Lar 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. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0643 and is authorized under FDA application NDA203255.

Identification & Billing

NDC Package Code
0078-0643-81
Package Description
1 KIT in 1 KIT * 6 mL in 1 VIAL, SINGLE-USE (0078-0783-61) * 2 mL in 1 SYRINGE
Product Code
0078-0643
11-Digit Billing Format
00078064381
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.

Clinical Specifications

Proprietary Name
Signifor Lar
Dosage Form
-
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
Novartis Pharmaceuticals Corporation
FDA Application #
NDA203255
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-15-2014
End Marketing Date
09-30-2022
Listing Expiration
09-30-2022
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 0078-0643-81 identifies a specific commercial package of 1 kit in 1 kit * 6 ml in 1 vial, single-use (0078-0783-61) * 2 ml in 1 syringe of Signifor Lar, labeled by Novartis Pharmaceuticals Corporation. 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 Novartis Pharmaceuticals Corporation on December 15, 2014. The current certification is valid through September 30, 2022.

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 Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078064381. 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 (4-4-2)
0078-0643-81
11-Digit CMS (5-4-2)
00078-0643-81

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