FDA.reportPublic FDA data

WINREVAIR 45 MG Injection

RxCUI
2678943
RxNorm name
WINREVAIR 45 MG Injection
Display name
WINREVAIR 45 MG Injection
Full name
WINREVAIR 45 MG Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:50

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761363Winrevairsotatercept-csrk351(a)Rx2026-09-01

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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
21693ee2-cd23-4137-ac67-066bb3a4a9b7WINREVAIR 45 MG Injection [PSN] · sotatercept-csrk 45 MG Injection [Winrevair] [SBD] · Winrevair 45 MG Injection [SY]38These highlights do not include all the information needed to use WINREVAIR safely and effectively. See full prescribing information for WINREVAIR. WINREVAIR™ (sotatercept-csrk) for injection, for subcutaneous use Initial U.S. Approval: 202420251208