FDA.reportPublic FDA data

Zemaira 1 MG Injection

RxCUI
991722
RxNorm name
Zemaira 1 MG Injection
Display name
Zemaira 1 MG Injection
Full name
Zemaira 1 MG Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:47

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125078ZemairaAlpha-1-Proteinase Inhibitor (Human)351(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 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
0c3354b5-a1d8-4f98-ad55-2eafe4265c4eZemaira 1 MG Injection [PSN] · alpha 1-proteinase inhibitor, human 1 MG Injection [Zemaira] [SBD] · Zemaira 1 MG Injection [SY]327These highlights do not include all the information needed to use ZEMAIRA safely and effectively. See full prescribing information for ZEMAIRA. ZEMAIRA ® (alpha 1 -proteinase inhibitor (human)) lyophilized powder for reconstitution for intravenous use Initial U.S. Approval: 200320240923
31a53b86-857b-a2d9-e063-6394a90abfb8Zemaira 1 MG Injection [PSN] · alpha 1-proteinase inhibitor, human 1 MG Injection [Zemaira] [SBD] · Zemaira 1 MG Injection [SY]3120250331