FDA.reportPublic FDA data

Gammaplex 10 % in 200 ML Injection

RxCUI
1876674
RxNorm name
Gammaplex 10 % in 200 ML Injection
Display name
Gammaplex 10 % in 200 ML Injection
Full name
Gammaplex 10 % in 200 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:50

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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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
2098af41-aec7-4af7-98bb-54f8ab55f30eGammaplex 10 % in 200 ML Injection [PSN] · 200 ML immunoglobulin G, human 100 MG/ML Injection [Gammaplex] [SBD] · 200 ML Gammaplex 100 MG/ML Injection [SY] · Gammaplex 10 % per 200 ML Injection [SY]416These highlights do not include all the information needed to use GAMMAPLEX ® 10% safely and effectively. See full prescribing information for GAMMAPLEX 10%. GAMMAPLEX 10% Immune Globulin Intravenous [Human], 10% Liquid Initial U.S. Approval: 201720251023