FDA.reportPublic FDA data

Rozerem 8 MG Oral Tablet

RxCUI
603162
RxNorm name
Rozerem 8 MG Oral Tablet
Display name
Rozerem 8 MG Oral Tablet
Full name
Rozerem 8 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:10

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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RozeremRAMELTEONTakeda Pharmaceuticals America, Inc.9de82310-70e8-47b9-b1fc-6c6848b994552026-04-15Warnings, Adverse reactionsExact identifier
rxcui: 603162

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 4 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
9de82310-70e8-47b9-b1fc-6c6848b99455Rozerem 8 MG Oral Tablet [PSN] · ramelteon 8 MG Oral Tablet [Rozerem] [SBD] · Rozerem 8 MG Oral Tablet [SY]320These highlights do not include all the information needed to use ROZEREM ® safely and effectively. See full prescribing information for ROZEREM. ROZEREM (ramelteon) tablets, for oral use Initial U.S. Approval: 200520260415
63823b05-b54b-4221-9be9-5865d9221ee1Rozerem 8 MG Oral Tablet [PSN] · ramelteon 8 MG Oral Tablet [Rozerem] [SBD] · Rozerem 8 MG Oral Tablet [SY]32These highlights do not include all the information needed to use ROZEREM safely and effectively. See full prescribing information for ROZEREM. ROZEREM (ramelteon) tablets Initial U.S. Approval: 200520171228
3740dcc6-9ee8-4187-9112-632050043240Rozerem 8 MG Oral Tablet [PSN] · ramelteon 8 MG Oral Tablet [Rozerem] [SBD] · Rozerem 8 MG Oral Tablet [SY]31These highlights do not include all the information needed to use ROZEREM safely and effectively. See full prescribing information for ROZEREM. ROZEREM (ramelteon) tablet, film coated for oral use Initial U.S. Approval: 200520101111
7a51d289-2013-4d37-adf2-91ea49df7932Rozerem 8 MG Oral Tablet [PSN] · ramelteon 8 MG Oral Tablet [Rozerem] [SBD] · Rozerem 8 MG Oral Tablet [SY]3120100120