FDA.reportPublic FDA data

100 ML albumin human, USP 50 MG/ML Injection [Albutein]

RxCUI
2669811
RxNorm name
100 ML albumin human, USP 50 MG/ML Injection [Albutein]
Display name
100 ML albumin human, USP 50 MG/ML Injection [Albutein]
Full name
100 ML albumin human, USP 50 MG/ML Injection [Albutein]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:13

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
102478AlbuteinAlbumin (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
a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945Albutein 5 % in 100 ML Injection [PSN] · 100 ML albumin human, USP 50 MG/ML Injection [Albutein] [SBD] · 100 ML Albutein 50 MG/ML Injection [SY] · Albutein 5 % per 100 ML Injection [SY] · Albutein 5 GM per 100 ML Injection [SY]513These highlights do not include all the information needed to use ALBUTEIN FlexBag 5% safely and effectively. See full prescribing information for ALBUTEIN FlexBag 5%. ALBUTEIN FlexBag 5% (albumin [human] U.S.P.) 5% solution Initial U.S. Approval: 197820250528