NDC 65649-150

Relistor

Methylnaltrexone Bromide

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

Product ID65649-150_1357dc78-e4c6-4f46-818b-b3bf1f02ef97
NDC65649-150
Product TypeHuman Prescription Drug
Proprietary NameRelistor
Generic NameMethylnaltrexone Bromide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2008-08-01
Marketing CategoryNDA / NDA
Application NumberNDA208271
Labeler NameSalix Pharmaceuticals, Inc.
Substance NameMETHYLNALTREXONE BROMIDE
Active Ingredient Strength150 mg/1
Pharm ClassesOpioid Antagonist [EPC],Opioid Antagonists [MoA],Quaternary Ammonium Compounds [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 65649-150-06

1 BOTTLE in 1 CARTON (65649-150-06) > 6 TABLET in 1 BOTTLE
Marketing Start Date2016-07-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65649-150-60 [65649015060]

Relistor TABLET
Marketing CategoryNDA
Application NumberNDA208271
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-07-19
Marketing End Date2017-06-30

NDC 65649-150-06 [65649015006]

Relistor TABLET
Marketing CategoryNDA
Application NumberNDA208271
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-07-19

NDC 65649-150-90 [65649015090]

Relistor TABLET
Marketing CategoryNDA
Application NumberNDA208271
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-07-19

Drug Details

Active Ingredients

IngredientStrength
METHYLNALTREXONE BROMIDE150 mg/1

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

    65649015090 RELISTOR 150 MG TABLET

    Pricing Unit: EA | 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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