FDA.reportPublic FDA data

Jelmyto 40 MG Powder for Pyelocalyceal Solution

RxCUI
2375823
RxNorm name
Jelmyto 40 MG Powder for Pyelocalyceal Solution
Display name
Jelmyto 40 MG Powder for Pyelocalyceal Solution
Full name
Jelmyto 40 MG Powder for Pyelocalyceal Solution
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:54

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
JELMYTOMITOMYCINUroGen Pharma, Inc.3d3d5053-5427-4a68-a40b-edb60699521e2025-07-09Warnings, Adverse reactionsExact identifier
rxcui: 2375823

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
3d3d5053-5427-4a68-a40b-edb60699521eJelmyto 40 MG Powder for Pyelocalyceal Solution [PSN] · mitomycin 40 MG Powder for Pyelocalyceal Solution [Jelmyto] [SBD] · Jelmyto 40 MG Powder for Pyelocalyceal Solution [SY] · Jelmyto 40 MG Powder for Ureteral Solution [SY]46These highlights do not include all the information needed to use JELMYTO safely and effectively. See full prescribing information for JELMYTO. JELMYTO ® (mitomycin) for pyelocalyceal solution Initial U.S. Approval: 197420250709