FDA.reportPublic FDA data

{2 (sotatercept-csrk 60 MG Injection) } Pack

RxCUI
2678950
RxNorm name
{2 (sotatercept-csrk 60 MG Injection) } Pack
Display name
{2 (sotatercept-csrk 60 MG Injection) } Pack
Full name
{2 (sotatercept-csrk 60 MG Injection) } Pack
Term type
GPCK
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-ac67-066bb3a4a9b7{2 (sotatercept-csrk 60 MG Injection) } Pack [GPCK] · sotatercept-csrk 60 MG, 2 Vial Kit [PSN] · sotatercept-csrk 60 MG, 2 Vial Kit [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