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  5. NDC Package Code: 65649-552-04 Relistor

NDC Package 65649-552-04 Relistor

Methylnaltrexone Bromide Injection, Solution Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Relistor
Non-Proprietary Name:
Methylnaltrexone Bromide
Substance Name:
Methylnaltrexone Bromide
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.
11-Digit NDC Billing Format:
65649055204
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to 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]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Salix Pharmaceuticals, Inc.
    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(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • METHYLNALTREXONE BROMIDE 8 mg/.4mL
    • Pharmacologic Class(es):
  • Opioid Antagonist - [EPC] (Established Pharmacologic Class)
  • Opioid Antagonists - [MoA] (Mechanism of Action)
  • Quaternary Ammonium Compounds - [CS]
    • Sample Package:
    No
    FDA Application Number:
    NDA021964
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    04-24-2008
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 65649-552-04 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    65649055204J2212Methylnaltrexone injection0.1 MG0.4780560

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65649-552-04?

    The NDC Packaged Code 65649-552-04 is assigned to a 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.. The product's dosage form is injection, solution and is administered via subcutaneous form.

    Is NDC 65649-552 included in the NDC Directory?

    Yes, Relistor with product code 65649-552 is active and included in the NDC Directory. The product was first marketed by Salix Pharmaceuticals, Inc. on April 24, 2008 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 65649-552-04?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 65649-552-04?

    The 11-digit format is 65649055204. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-265649-552-045-4-265649-0552-04