FDA.reportPublic FDA data

Gammaplex 20 GM per 400 ML Injection

RxCUI
1809514
RxNorm name
Gammaplex 20 GM per 400 ML Injection
Display name
Gammaplex 20 GM per 400 ML Injection
Full name
Gammaplex 20 GM per 400 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:03

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125329GammaplexImmune 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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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
6c3ce068-59f0-413b-9f93-85fb597d55e5Gammaplex 5 % in 400 ML Injection [PSN] · 400 ML immunoglobulin G, human 50 MG/ML Injection [Gammaplex] [SBD] · 400 ML Gammaplex 50 MG/ML Injection [SY] · Gammaplex 20 GM per 400 ML Injection [SY] · Gammaplex 5 % per 400 ML Injection [SY]526These highlights do not include all the information needed to use GAMMAPLEX 5% ® safely and effectively. See full prescribing information for GAMMAPLEX 5% ® . GAMMAPLEX 5% Immune Globulin Intravenous (Human), 5% Liquid, for intravenous use Initial U.S. Approval: 200920250916