Relistor Tablet
NDC Package 65649-150-06

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

Package Information

Relistor (methylnaltrexone bromide) tablets is a medication used to treat constipation caused by opioid medication. This formulation utilizes a tablet delivery system. Marketed by Salix Pharmaceuticals, Inc., this product is identified by NDC 65649-150 and is authorized under FDA application NDA208271.

Identification & Billing

NDC Package Code
65649-150-06
Package Description
1 BOTTLE in 1 CARTON / 6 TABLET in 1 BOTTLE
Product Code
65649-150
11-Digit Billing Format
65649015006
RxNorm Crosswalk
  • RxCUI: 1244060 - methylnaltrexone bromide 12 MG in 0.6 ML Prefilled Syringe
  • RxCUI: 1244060 - 0.6 ML methylnaltrexone bromide 20 MG/ML Prefilled Syringe
  • RxCUI: 1244060 - methylnaltrexone bromide 12 MG per 0.6 ML Prefilled Syringe
  • RxCUI: 1244062 - RELISTOR 12 MG in 0.6 ML Prefilled Syringe
  • RxCUI: 1244062 - 0.6 ML methylnaltrexone bromide 20 MG/ML Prefilled Syringe [Relistor]

Clinical Specifications

Proprietary Name
Relistor
Non-Proprietary Name
Methylnaltrexone Bromide
Substance Name
Methylnaltrexone Bromide
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METHYLNALTREXONE BROMIDE 150 mg/1
Pharmacologic Class
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.
Product Type
Human Prescription Drug
FDA Application #
NDA208271
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-01-2008
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65649-150). Click a package code to view its specific billing and regulatory data.

65649-150-60
60 TABLET in 1 BOTTLE
65649-150-90
90 TABLET in 1 BOTTLE

* 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 65649-150-06 identifies a specific commercial package of 1 bottle in 1 carton / 6 tablet in 1 bottle of Relistor, a human prescription drug labeled by Salix Pharmaceuticals, Inc.. This tablet is formulated for oral use and contains methylnaltrexone bromide 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 Salix Pharmaceuticals, Inc. on August 01, 2008. The current certification is valid through December 31, 2027.

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: 65649015006. 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)
65649-150-06
11-Digit CMS (5-4-2)
65649-0150-06

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