FDA.reportPublic FDA data

Gammaplex 10 % per 50 ML Injection

RxCUI
1876671
RxNorm name
Gammaplex 10 % per 50 ML Injection
Display name
Gammaplex 10 % per 50 ML Injection
Full name
Gammaplex 10 % per 50 ML Injection
Term type
SY
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)Disc2026-06-01

RxNav Current And Historical NDCs#

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UNII Substances#

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No records found.

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
2098af41-aec7-4af7-98bb-54f8ab55f30eGammaplex 10 % per 50 ML InjectionSY16These 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
2098af41-aec7-4af7-98bb-54f8ab55f30e50 ML Gammaplex 100 MG/ML InjectionSY16These 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
2098af41-aec7-4af7-98bb-54f8ab55f30e50 ML immunoglobulin G, human 100 MG/ML Injection [Gammaplex]SBD16These 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
2098af41-aec7-4af7-98bb-54f8ab55f30eGammaplex 10 % in 50 ML InjectionPSN16These 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