NDC 65649-552

Relistor

Methylnaltrexone Bromide

Relistor is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Salix Pharmaceuticals, Inc.. The primary component is Methylnaltrexone Bromide.

Product ID65649-552_1357dc78-e4c6-4f46-818b-b3bf1f02ef97
NDC65649-552
Product TypeHuman Prescription Drug
Proprietary NameRelistor
Generic NameMethylnaltrexone Bromide
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2008-04-24
Marketing CategoryNDA / NDA
Application NumberNDA021964
Labeler NameSalix Pharmaceuticals, Inc.
Substance NameMETHYLNALTREXONE BROMIDE
Active Ingredient Strength8 mg/.4mL
Pharm ClassesOpioid Antagonist [EPC],Opioid Antagonists [MoA],Quaternary Ammonium Compounds [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 65649-552-04

7 BLISTER PACK in 1 CARTON (65649-552-04) > 1 SYRINGE in 1 BLISTER PACK > .4 mL in 1 SYRINGE
Marketing Start Date2008-04-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65649-552-04 [65649055204]

Relistor INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021964
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2008-04-24

Drug Details

Active Ingredients

IngredientStrength
METHYLNALTREXONE BROMIDE8 mg/.4mL

OpenFDA Data

SPL SET ID:c488fb7c-0a5b-487c-b452-996809d1cb99
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1801519
  • 1244062
  • 1244063
  • 979115
  • 1801514
  • 979113
  • 1244064
  • 1244060
  • Pharmacological Class

    • Opioid Antagonist [EPC]
    • Opioid Antagonists [MoA]
    • Quaternary Ammonium Compounds [CS]

    Medicade Reported Pricing

    65649055204 RELISTOR 8 MG/0.4 ML SYRINGE

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "Relistor" or generic name "Methylnaltrexone Bromide"

    NDCBrand NameGeneric Name
    65649-150RelistorMethylnaltrexone bromide
    65649-551RelistorMethylnaltrexone bromide
    65649-552RelistorMethylnaltrexone bromide

    Trademark Results [Relistor]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    RELISTOR
    RELISTOR
    78939607 3535582 Live/Registered
    SALIX PHARMACEUTICALS, INC.
    2006-07-28
    RELISTOR
    RELISTOR
    77324836 3592407 Dead/Cancelled
    SALIX PHARMACEUTICALS, INC.
    2007-11-08

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