Relistor
NDC Package 65649-556-03

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.

Relistor is a medication used to treat constipation caused by opioid medication. Marketed by Salix Pharmaceuticals, Inc., this product is identified by NDC 65649-556 and is authorized under FDA application NDA021964.

Identification & Billing

NDC Package Code
65649-556-03
Package Description
7 TRAY in 1 CARTON / 1 SYRINGE in 1 TRAY / .6 mL in 1 SYRINGE
Product Code
65649-556
11-Digit Billing Format
65649055603

Clinical Specifications

Proprietary Name
Relistor
Dosage Form
-
Usage Information
This medication is used to treat constipation caused by opioid medication. It blocks the effect of opioids on the gut without blocking the effect on pain. Methylnaltrexone belongs to a class of medications known as opioid antagonists.

Regulatory & Marketing

Labeler Name
Salix Pharmaceuticals, Inc.
FDA Application #
NDA021964
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-01-2010
End Marketing Date
04-11-2012
Listing Expiration
04-11-2012
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 65649-556-03 identifies a specific commercial package of 7 tray in 1 carton / 1 syringe in 1 tray / .6 ml in 1 syringe of Relistor, labeled by Salix Pharmaceuticals, 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 Salix Pharmaceuticals, Inc. on October 01, 2010. The current certification is valid through April 11, 2012.

What are the primary indications for this medication?

This medication is used to treat constipation caused by opioid medication. It blocks the effect of opioids on the gut without blocking the effect on pain. Methylnaltrexone belongs to a class of medications known as opioid antagonists.

How is this Salix Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65649055603. 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)
65649-556-03
11-Digit CMS (5-4-2)
65649-0556-03

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