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#

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.

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#

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

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
6945b183-18d3-40de-afd1-c88e33cc1a63Opsynvi 10 MG / 20 MG Oral Tablet [PSN] · macitentan 10 MG / tadalafil 20 MG Oral Tablet [Opsynvi] [SBD] · Opsynvi (macitentan 10 MG / tadalafil 20 MG) Oral Tablet [SY]33These 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