FDA.reportPublic FDA data

methylnaltrexone bromide 12 MG in 0.6 ML Prefilled Syringe

RxCUI
1244060
RxNorm name
methylnaltrexone bromide 12 MG in 0.6 ML Prefilled Syringe
Display name
methylnaltrexone bromide 12 MG in 0.6 ML Prefilled Syringe
Full name
methylnaltrexone bromide 12 MG in 0.6 ML Prefilled Syringe
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:20

RxNav Current And Historical NDCs#

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UNII Substances#

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openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RelistorMETHYLNALTREXONE BROMIDESalix Pharmaceuticals, Inc.c488fb7c-0a5b-487c-b452-996809d1cb992024-05-01Warnings, Adverse reactionsExact identifier
rxcui: 1244060

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
c488fb7c-0a5b-487c-b452-996809d1cb99methylnaltrexone bromide 12 MG in 0.6 ML Prefilled SyringePSN68These highlights do not include all the information needed to use RELISTOR safely and effectively. See full prescribing information for RELISTOR. RELISTOR ® (methylnaltrexone bromide) tablets, for oral use RELISTOR ® (methylnaltrexone bromide) injection, for subcutaneous use Initial U.S. Approval: 200820240501
c488fb7c-0a5b-487c-b452-996809d1cb990.6 ML methylnaltrexone bromide 20 MG/ML Prefilled SyringeSCD68These highlights do not include all the information needed to use RELISTOR safely and effectively. See full prescribing information for RELISTOR. RELISTOR ® (methylnaltrexone bromide) tablets, for oral use RELISTOR ® (methylnaltrexone bromide) injection, for subcutaneous use Initial U.S. Approval: 200820240501
c488fb7c-0a5b-487c-b452-996809d1cb99methylnaltrexone bromide 12 MG per 0.6 ML Prefilled SyringeSY68These highlights do not include all the information needed to use RELISTOR safely and effectively. See full prescribing information for RELISTOR. RELISTOR ® (methylnaltrexone bromide) tablets, for oral use RELISTOR ® (methylnaltrexone bromide) injection, for subcutaneous use Initial U.S. Approval: 200820240501