FDA.reportPublic FDA data

400 ML immunoglobulin G, human 100 MG/ML Injection

RxCUI
1809524
RxNorm name
400 ML immunoglobulin G, human 100 MG/ML Injection
Display name
400 ML immunoglobulin G, human 100 MG/ML Injection
Full name
400 ML immunoglobulin G, human 100 MG/ML Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:15

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125201PrivigenImmune Globulin Intravenous (Human), 10% Liquid351(a)Rx2026-08-01
125046Gammaked, Gamunex-CImmune Globulin Injection (Human) 10% Caprylate/Chromatography Purified351(a)Rx2026-08-01

RxNav Current And Historical NDCs#

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UNII Substances#

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DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
ade6b84a-e95b-0a49-3296-f56208fdf35bimmunoglobulin G, human 10 % in 400 ML Injection [PSN] · 400 ML immunoglobulin G, human 100 MG/ML Injection [SCD] · immunoglobulin G, human 10 % per 400 ML Injection [SY] · immunoglobulin G, human 40 GM per 400 ML Injection [SY]437These highlights do not include all the information needed to use GAMUNEX ® -C safely and effectively. See full prescribing information for GAMUNEX-C. GAMUNEX ® -C, [Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified] Initial U.S. Approval: 200320220429
7e5649da-75be-4a42-8eeb-4aeba562c401immunoglobulin G, human 10 % in 400 ML Injection [PSN] · 400 ML immunoglobulin G, human 100 MG/ML Injection [SCD] · immunoglobulin G, human 10 % per 400 ML Injection [SY] · immunoglobulin G, human 40 GM per 400 ML Injection [SY]429These highlights do not include all the information needed to use PRIVIGEN safely and effectively. See full prescribing information for PRIVIGEN. PRIVIGEN, Immune Globulin Intravenous (Human), 10% Liquid, for intravenous use Initial U.S. Approval: 200720260504
4fe97dac-d952-40f5-9c6a-67cda048ad8fimmunoglobulin G, human 10 % in 400 ML Injection [PSN] · 400 ML immunoglobulin G, human 100 MG/ML Injection [SCD] · immunoglobulin G, human 10 % per 400 ML Injection [SY] · immunoglobulin G, human 40 GM per 400 ML Injection [SY]43These highlights do not include all the information needed to use GAMUNEX-C FlexBag safely and effectively. See full prescribing information for GAMUNEX-C FlexBag. GAMUNEX-C FlexBag, [immune globulin injection (human), 10%, caprylate/chromatography purified] for intravenous use. Initial U.S. Approval: 200320260430