FDA.reportPublic FDA data

Berinert 500 UNT Injection

RxCUI
867381
RxNorm name
Berinert 500 UNT Injection
Display name
Berinert 500 UNT Injection
Full name
Berinert 500 UNT Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:08

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125287BerinertC1 Esterase Inhibitor (Human)351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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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
8ea0c7fe-da9d-4218-a080-0509e09bedc6Berinert 500 UNT Injection [PSN] · C1 esterase inhibitor (human) 500 UNT Injection [Berinert] [SBD] · Berinert 500 UNT Injection [SY]333These highlights do not include all the information needed to use BERINERT safely and effectively. See full prescribing information for BERINERT. BERINERT [C1 Esterase Inhibitor (Human)] For intravenous use. Freeze-Dried Powder for Reconstitution. Initial U.S. Approval: 200920210921