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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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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rozerem	RAMELTEON	Takeda Pharmaceuticals America, Inc.	9de82310-70e8-47b9-b1fc-6c6848b99455	2026-04-15	Warnings, Adverse reactions	Exact identifier rxcui: 603162

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set ID	RxNorm string	TTY	SPL version	Label	Effective
9de82310-70e8-47b9-b1fc-6c6848b99455	Rozerem 8 MG Oral Tablet	PSN	20	These 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: 2005	20260415
9de82310-70e8-47b9-b1fc-6c6848b99455	ramelteon 8 MG Oral Tablet [Rozerem]	SBD	20	These 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: 2005	20260415
9de82310-70e8-47b9-b1fc-6c6848b99455	Rozerem 8 MG Oral Tablet	SY	20	These 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: 2005	20260415
63823b05-b54b-4221-9be9-5865d9221ee1	ramelteon 8 MG Oral Tablet [Rozerem]	SBD	2	These 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: 2005	20171228
63823b05-b54b-4221-9be9-5865d9221ee1	Rozerem 8 MG Oral Tablet	PSN	2	These 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: 2005	20171228
63823b05-b54b-4221-9be9-5865d9221ee1	Rozerem 8 MG Oral Tablet	SY	2	These 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: 2005	20171228
3740dcc6-9ee8-4187-9112-632050043240	Rozerem 8 MG Oral Tablet	SY	1	These 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: 2005	20101111
3740dcc6-9ee8-4187-9112-632050043240	Rozerem 8 MG Oral Tablet	PSN	1	These 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: 2005	20101111
3740dcc6-9ee8-4187-9112-632050043240	ramelteon 8 MG Oral Tablet [Rozerem]	SBD	1	These 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: 2005	20101111
7a51d289-2013-4d37-adf2-91ea49df7932	Rozerem 8 MG Oral Tablet	SY	1		20100120
7a51d289-2013-4d37-adf2-91ea49df7932	ramelteon 8 MG Oral Tablet [Rozerem]	SBD	1		20100120
7a51d289-2013-4d37-adf2-91ea49df7932	Rozerem 8 MG Oral Tablet	PSN	1		20100120