FDA.reportPublic FDA data

macitentan 10 MG / tadalafil 20 MG Oral Tablet

RxCUI
2677765
RxNorm name
macitentan 10 MG / tadalafil 20 MG Oral Tablet
Display name
macitentan 10 MG / tadalafil 20 MG Oral Tablet
Full name
macitentan 10 MG / tadalafil 20 MG Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:02

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
6945b183-18d3-40de-afd1-c88e33cc1a63macitentan 10 MG / tadalafil 20 MG Oral TabletSY3These highlights do not include all the information needed to use OPSYNVI safely and effectively. See full prescribing information for OPSYNVI. OPSYNVI ® (macitentan and tadalafil) tablets, for oral use Initial U.S. Approval: 202420250411
6945b183-18d3-40de-afd1-c88e33cc1a63macitentan 10 MG / tadalafil 20 MG Oral TabletSCD3These highlights do not include all the information needed to use OPSYNVI safely and effectively. See full prescribing information for OPSYNVI. OPSYNVI ® (macitentan and tadalafil) tablets, for oral use Initial U.S. Approval: 202420250411
6945b183-18d3-40de-afd1-c88e33cc1a63macitentan 10 MG / tadalafil 20 MG Oral TabletPSN3These highlights do not include all the information needed to use OPSYNVI safely and effectively. See full prescribing information for OPSYNVI. OPSYNVI ® (macitentan and tadalafil) tablets, for oral use Initial U.S. Approval: 202420250411