FDA.reportPublic FDA data

mesalamine 500 MG Extended Release Oral Capsule [Pentasa]

RxCUI
580286
RxNorm name
mesalamine 500 MG Extended Release Oral Capsule [Pentasa]
Display name
mesalamine 500 MG Extended Release Oral Capsule [Pentasa]
Full name
mesalamine 500 MG Extended Release Oral Capsule [Pentasa]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:25

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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No records found.

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PentasaMESALAMINETakeda Pharmaceuticals America, Inc.e39d9a3d-5d3a-4bb6-aab1-fdbb2a5986062025-01-15Warnings, Adverse reactionsExact identifier
rxcui: 580286

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
e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606Pentasa 500 MG Extended Release Oral Capsule [PSN] · mesalamine 500 MG Extended Release Oral Capsule [Pentasa] [SBD] · Pentasa 500 MG Extended Release Oral Capsule [SY]342These highlights do not include all the information needed to use PENTASA safely and effectively. See full prescribing information for PENTASA. PENTASA ® (mesalamine) extended-release capsules, for oral use Initial U.S. Approval: 198720250115