Cyclosporine
NDC Package 0517-0866-10

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.

Cyclosporine is used to prevent organ rejection in people who have received a liver, kidney, or heart transplant. Marketed by American Regent, Inc., this product is identified by NDC 0517-0866.

Identification & Billing

NDC Package Code
0517-0866-10
Package Description
10 AMPULE in 1 CARTON / 5 mL in 1 AMPULE
Product Code
0517-0866
11-Digit Billing Format
00517086610
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Cyclosporine
Dosage Form
-
Usage Information
Cyclosporine is used to prevent organ rejection in people who have received a liver, kidney, or heart transplant. It is usually taken along with other medications to allow your new organ to function normally. Cyclosporine belongs to a class of drugs known as immunosuppressants. It works by weakening the immune system to help your body accept the new organ as if it were your own.

Regulatory & Marketing

Labeler Name
American Regent, Inc.
Marketing Category
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE -
Start Marketing Date
10-07-2003
End Marketing Date
04-30-2021
Listing Expiration
04-30-2021
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 0517-0866-10 identifies a specific commercial package of 10 ampule in 1 carton / 5 ml in 1 ampule of Cyclosporine, labeled by American Regent, 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 American Regent, Inc. on October 07, 2003. The current certification is valid through April 30, 2021.

What are the primary indications for this medication?

Cyclosporine is used to prevent organ rejection in people who have received a liver, kidney, or heart transplant. It is usually taken along with other medications to allow your new organ to function normally. Cyclosporine belongs to a class of drugs known as immunosuppressants. It works by weakening the immune system to help your body accept the new organ as if it were your own.

How is this American Regent, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00517086610. 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 (4-4-2)
0517-0866-10
11-Digit CMS (5-4-2)
00517-0866-10

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