Opsumit 10 MG Oral Tablet

RxCUI: 1442143
RxNorm name: Opsumit 10 MG Oral Tablet
Display name: Opsumit 10 MG Oral Tablet
Full name: Opsumit 10 MG Oral Tablet
Term type: SY
Status: DailyMed mapping
Updated: 2026-06-04 23:38:49

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
OPSUMIT	MACITENTAN	Actelion Pharmaceuticals US, Inc.	1e484a50-55db-4b85-8c57-6cd1b0353abd	2025-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1442143

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set ID	RxNorm string	TTY	SPL version	Label	Effective
1e484a50-55db-4b85-8c57-6cd1b0353abd	Opsumit 10 MG Oral Tablet	SY	35	These highlights do not include all the information needed to use OPSUMIT safely and effectively. See full prescribing information for OPSUMIT. OPSUMIT ® (macitentan) tablets, for oral use Initial U.S. Approval: 2013	20250411
1e484a50-55db-4b85-8c57-6cd1b0353abd	Opsumit 10 MG Oral Tablet	PSN	35	These highlights do not include all the information needed to use OPSUMIT safely and effectively. See full prescribing information for OPSUMIT. OPSUMIT ® (macitentan) tablets, for oral use Initial U.S. Approval: 2013	20250411
1e484a50-55db-4b85-8c57-6cd1b0353abd	macitentan 10 MG Oral Tablet [Opsumit]	SBD	35	These highlights do not include all the information needed to use OPSUMIT safely and effectively. See full prescribing information for OPSUMIT. OPSUMIT ® (macitentan) tablets, for oral use Initial U.S. Approval: 2013	20250411