FDA.reportPublic FDA data

FLEXBUMIN 5 % in 250 ML Injection

RxCUI
1741986
RxNorm name
FLEXBUMIN 5 % in 250 ML Injection
Display name
FLEXBUMIN 5 % in 250 ML Injection
Full name
FLEXBUMIN 5 % in 250 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:05

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
101452Buminate, FlexbuminAlbumin (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
79094f4e-5f5c-44d6-b563-d6078eafe83aFLEXBUMIN 5 % in 250 ML Injection [PSN] · 250 ML albumin human, USP 50 MG/ML Injection [Flexbumin] [SBD] · Flexbumin 12.5 GM per 250 ML Injection [SY] · Flexbumin 5 % per 250 ML Injection [SY]414These highlights do not include all the information needed to use FLEXBUMIN ® 5% safely and effectively. See full prescribing information for FLEXBUMIN 5%. FLEXBUMIN ® 5% Albumin (Human), USP, 5% Solution, for intravenous use Initial U.S. Approval: 200520241218