FDA.reportPublic FDA data

mesalamine 800 MG Delayed Release Oral Tablet

RxCUI
833234
RxNorm name
mesalamine 800 MG Delayed Release Oral Tablet
Display name
mesalamine 800 MG Delayed Release Oral Tablet
Full name
mesalamine 800 MG Delayed Release Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:45

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
mesalamineMESALAMINEZydus Pharmaceuticals USA Inc.ad8c7930-92e2-4372-a874-da22b9ae333e2026-07-14Warnings, Adverse reactionsExact identifier
rxcui: 833234
MesalamineMESALAMINEAvKARE22f3ee49-ac57-84f5-e063-6394a90aae912026-01-14Warnings, Adverse reactionsExact identifier
rxcui: 833234
mesalamineMESALAMINEZydus Lifesciences Limited52d96501-47f3-45d8-a181-98763b9f89652024-11-30Exact identifier
rxcui: 833234
MesalamineMESALAMINEAmerican Health Packaginga74ab9f4-ffcd-4bbf-88a5-342e6a38aabb2024-11-21Warnings, Adverse reactionsExact identifier
rxcui: 833234
MesalamineMESALAMINETeva Pharmaceuticals, Inc.e3b84397-a5a5-40cf-8145-0584103d465f2024-06-28Warnings, Adverse reactionsExact identifier
rxcui: 833234
MesalamineMESALAMINEAmneal Pharmaceuticals LLC00f77203-3615-47e8-ae25-6e1cf8a2a00a2024-05-23Warnings, Adverse reactionsExact identifier
rxcui: 833234

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 7 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
00f77203-3615-47e8-ae25-6e1cf8a2a00amesalamine 800 MG Delayed Release Oral Tablet [PSN] · mesalamine 800 MG Delayed Release Oral Tablet [SCD] · mesalazine 800 MG Delayed Release Oral Tablet [SY]310These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE delayed-release tablets, for oral use Initial U.S. Approval: 198720240523
ad8c7930-92e2-4372-a874-da22b9ae333emesalamine 800 MG Delayed Release Oral Tablet [PSN] · mesalamine 800 MG Delayed Release Oral Tablet [SCD] · mesalazine 800 MG Delayed Release Oral Tablet [SY]38These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE delayed-release tablets, for oral use Initial U.S. Approval: 198720230811
52d96501-47f3-45d8-a181-98763b9f8965mesalamine 800 MG Delayed Release Oral Tablet [PSN] · mesalamine 800 MG Delayed Release Oral Tablet [SCD] · mesalazine 800 MG Delayed Release Oral Tablet [SY]37MESALAMINE DELAYED-RELEASE TABLETS20241130
25998d2b-4260-4cf8-8a54-a15ee3292da4mesalamine 800 MG Delayed Release Oral Tablet [PSN] · mesalamine 800 MG Delayed Release Oral Tablet [SCD] · mesalazine 800 MG Delayed Release Oral Tablet [SY]37These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. Mesalamine delayed-release tablets, for oral use Initial U.S. Approval: 198720210304
a74ab9f4-ffcd-4bbf-88a5-342e6a38aabbmesalamine 800 MG Delayed Release Oral Tablet [PSN] · mesalamine 800 MG Delayed Release Oral Tablet [SCD] · mesalazine 800 MG Delayed Release Oral Tablet [SY]36These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE delayed-release tablets, for oral use Initial U.S. Approval: 198720241121
22f3ee49-ac57-84f5-e063-6394a90aae91mesalamine 800 MG Delayed Release Oral Tablet [PSN] · mesalamine 800 MG Delayed Release Oral Tablet [SCD] · mesalazine 800 MG Delayed Release Oral Tablet [SY]32Mesalamine Delayed-Release Tablets, USP Rx only These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. Initial U.S. Approval: 198720260114
e3b84397-a5a5-40cf-8145-0584103d465fmesalamine 800 MG Delayed Release Oral Tablet [PSN] · mesalamine 800 MG Delayed Release Oral Tablet [SCD] · mesalazine 800 MG Delayed Release Oral Tablet [SY]31These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS . MESALAMINE delayed-release tablets , for oral use Initial U.S. Approval: 198720240628