FDA.reportPublic FDA data

Opsynvi (macitentan 10 MG / tadalafil 20 MG) Oral Tablet

RxCUI
2677771
RxNorm name
Opsynvi (macitentan 10 MG / tadalafil 20 MG) Oral Tablet
Display name
Opsynvi (macitentan 10 MG / tadalafil 20 MG) Oral Tablet
Full name
Opsynvi (macitentan 10 MG / tadalafil 20 MG) Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:02

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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OPSYNVIMACITENTAN AND TADALAFILActelion Pharmaceuticals US, Inc.6945b183-18d3-40de-afd1-c88e33cc1a632025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2677771

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
6945b183-18d3-40de-afd1-c88e33cc1a63Opsynvi (macitentan 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-c88e33cc1a63Opsynvi 10 MG / 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
6945b183-18d3-40de-afd1-c88e33cc1a63macitentan 10 MG / tadalafil 20 MG Oral Tablet [Opsynvi]SBD3These 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