Relistor Injection, Solution
NDC Package 65649-552-04

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

Package Information

Relistor (methylnaltrexone bromide) injection is a medication used to treat constipation caused by opioid medication. This formulation utilizes a injection, solution delivery system. Marketed by Salix Pharmaceuticals, Inc., this product is identified by NDC 65649-552 and is authorized under FDA application NDA021964.

Identification & Billing

NDC Package Code
65649-552-04
Package Description
7 BLISTER PACK in 1 CARTON / 1 SYRINGE in 1 BLISTER PACK / .4 mL in 1 SYRINGE
Product Code
65649-552
11-Digit Billing Format
65649055204
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
METHYLNALTREXONE BROMIDE 8 mg/.4mL
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 #
NDA021964
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-24-2008
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65649-552-04 identifies a specific commercial package of 7 blister pack in 1 carton / 1 syringe in 1 blister pack / .4 ml in 1 syringe of Relistor, a human prescription drug labeled by Salix Pharmaceuticals, Inc.. This injection, solution is formulated for subcutaneous 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 April 24, 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: 65649055204. 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)
65649-552-04
11-Digit CMS (5-4-2)
65649-0552-04

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