FDA.reportPublic FDA data

200 ML immunoglobulin G, human 50 MG/ML Injection [Gammaplex]

RxCUI
1809513
RxNorm name
200 ML immunoglobulin G, human 50 MG/ML Injection [Gammaplex]
Display name
200 ML immunoglobulin G, human 50 MG/ML Injection [Gammaplex]
Full name
200 ML immunoglobulin G, human 50 MG/ML Injection [Gammaplex]
Term type
SBD
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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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
6c3ce068-59f0-413b-9f93-85fb597d55e5Gammaplex 5 % in 200 ML Injection [PSN] · 200 ML immunoglobulin G, human 50 MG/ML Injection [Gammaplex] [SBD] · 200 ML Gammaplex 50 MG/ML Injection [SY] · Gammaplex 10 GM per 200 ML Injection [SY] · Gammaplex 5 % per 200 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