FDA.reportPublic FDA data

Flebogamma 20 GM per 400 ML Injection

RxCUI
1809475
RxNorm name
Flebogamma 20 GM per 400 ML Injection
Display name
Flebogamma 20 GM per 400 ML Injection
Full name
Flebogamma 20 GM per 400 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:52

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125077Flebogamma 5%, Flebogamma 5% DifImmune Globulin Intravenous (Human)351(a)Disc2026-09-01

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
2cf22c72-64ac-45be-b7c6-d20340730096Flebogamma 5 % in 400 ML Injection [PSN] · 400 ML immunoglobulin G, human 50 MG/ML Injection [Flebogamma] [SBD] · 400 ML Flebogamma 50 MG/ML Injection [SY] · Flebogamma 20 GM per 400 ML Injection [SY] · Flebogamma 5 % per 400 ML Injection [SY]534These highlights do not include all the information needed to use FLEBOGAMMA 5% DIF safely and effectively. See full prescribing information for FLEBOGAMMA 5% DIF. FLEBOGAMMA 5% DIF (immune globulin intravenous [human]), solution for intravenous administration Initial U.S. Approval: 200620251117