Signifor Injection
NDC Package 55292-133-60

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

Package Information

Signifor (pasireotide) injection is pasireotide is used to treat a certain condition (Cushing's disease) when surgery has not been fully successful or cannot be used to correct the condition. This formulation utilizes a injection delivery system. Marketed by Recordati Rare Diseases, Inc., this product is identified by NDC 55292-133 and is authorized under FDA application NDA200677.

Identification & Billing

NDC Package Code
55292-133-60
Package Description
60 PACKAGE in 1 BOX / 6 AMPULE in 1 PACKAGE (55292-133-06) / 1 mL in 1 AMPULE (55292-133-01)
Product Code
55292-133
11-Digit Billing Format
55292013360
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Signifor
Non-Proprietary Name
Pasireotide
Substance Name
Pasireotide
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
PASIREOTIDE .9 mg/mL
Pharmacologic Class
Usage Information
Pasireotide is 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 #
NDA200677
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-14-2012
Listing Expiration
12-31-2027
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 55292-133-60 identifies a specific commercial package of 60 package in 1 box / 6 ampule in 1 package (55292-133-06) / 1 ml in 1 ampule (55292-133-01) of Signifor, a human prescription drug labeled by Recordati Rare Diseases, Inc.. This injection is formulated for subcutaneous use and contains pasireotide 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 14, 2012. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Pasireotide is 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: 55292013360. 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 (5-3-2)
55292-133-60
11-Digit CMS (5-4-2)
55292-0133-60

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