FDA.reportPublic FDA data

{2 (sotatercept-csrk 45 MG Injection [Winrevair]) } Pack [Winrevair 45 MG, 2 Vial Kit]

RxCUI
2678949
RxNorm name
{2 (sotatercept-csrk 45 MG Injection [Winrevair]) } Pack [Winrevair 45 MG, 2 Vial Kit]
Display name
{2 (sotatercept-csrk 45 MG Injection [Winrevair]) } Pack [Winrevair 45 MG, 2 Vial Kit]
Full name
{2 (sotatercept-csrk 45 MG Injection [Winrevair]) } Pack [Winrevair 45 MG, 2 Vial Kit]
Term type
BPCK
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)Rx2026-06-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

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UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
21693ee2-cd23-4137-ac67-066bb3a4a9b7{2 (sotatercept-csrk 45 MG Injection [Winrevair]) } Pack [Winrevair 45 MG, 2 Vial Kit]BPCK8These 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
21693ee2-cd23-4137-ac67-066bb3a4a9b7Winrevair 45 MG, 2 Vial KitSY8These 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
21693ee2-cd23-4137-ac67-066bb3a4a9b7Winrevair 45 MG, 2 Vial KitPSN8These 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