FDA.reportPublic FDA data

immunoglobulin G, human 5 GM Injection

RxCUI
1809728
RxNorm name
immunoglobulin G, human 5 GM Injection
Display name
immunoglobulin G, human 5 GM Injection
Full name
immunoglobulin G, human 5 GM Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:19

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103133Gammagard, Gammagard S/D, IveegamImmune Globulin Intravenous (Human)351(a)Disc2026-06-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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No records found.

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
bf8df9fd-bfdd-47c2-84d2-d91e50947bf6immunoglobulin G, human 5 GM InjectionPSN12These highlights do not include all the information needed to use GAMMAGARD S/D safely and effectively. See full prescribing information for GAMMAGARD S/D GAMMAGARD ® S/D, Immune Globulin Intravenous (Human) IgA less than 1 microgram per mL in a 5% Solution Initial U.S. Approval: 199420251125
bf8df9fd-bfdd-47c2-84d2-d91e50947bf6immunoglobulin G, human 5000 MG InjectionSCD12These highlights do not include all the information needed to use GAMMAGARD S/D safely and effectively. See full prescribing information for GAMMAGARD S/D GAMMAGARD ® S/D, Immune Globulin Intravenous (Human) IgA less than 1 microgram per mL in a 5% Solution Initial U.S. Approval: 199420251125
bf8df9fd-bfdd-47c2-84d2-d91e50947bf6immunoglobulin G, human 5 GM InjectionSY12These highlights do not include all the information needed to use GAMMAGARD S/D safely and effectively. See full prescribing information for GAMMAGARD S/D GAMMAGARD ® S/D, Immune Globulin Intravenous (Human) IgA less than 1 microgram per mL in a 5% Solution Initial U.S. Approval: 199420251125