FDA.reportPublic FDA data

immunoglobulin G, human 20 GM per 400 ML Injection

RxCUI
1809474
RxNorm name
immunoglobulin G, human 20 GM per 400 ML Injection
Display name
immunoglobulin G, human 20 GM per 400 ML Injection
Full name
immunoglobulin G, human 20 GM per 400 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:52

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125329GammaplexImmune Globulin Intravenous (Human)351(a)Disc2026-06-01
125077Flebogamma 5%, Flebogamma 5% DifImmune Globulin Intravenous (Human)351(a)Disc2026-06-01

RxNav Current And Historical NDCs#

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UNII Substances#

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DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
2cf22c72-64ac-45be-b7c6-d20340730096immunoglobulin G, human 5 % per 400 ML InjectionSY34These highlights do not include all the information needed to use FLEBOGAMMA 5% DIF safely and effectively. See full prescribing information for FLEBOGAMMA 5% DIF. FLEBOGAMMA 5% DIF (immune globulin intravenous [human]), solution for intravenous administration Initial U.S. Approval: 200620251117
2cf22c72-64ac-45be-b7c6-d20340730096400 ML immunoglobulin G, human 50 MG/ML InjectionSCD34These highlights do not include all the information needed to use FLEBOGAMMA 5% DIF safely and effectively. See full prescribing information for FLEBOGAMMA 5% DIF. FLEBOGAMMA 5% DIF (immune globulin intravenous [human]), solution for intravenous administration Initial U.S. Approval: 200620251117
2cf22c72-64ac-45be-b7c6-d20340730096immunoglobulin G, human 5 % in 400 ML InjectionPSN34These highlights do not include all the information needed to use FLEBOGAMMA 5% DIF safely and effectively. See full prescribing information for FLEBOGAMMA 5% DIF. FLEBOGAMMA 5% DIF (immune globulin intravenous [human]), solution for intravenous administration Initial U.S. Approval: 200620251117
2cf22c72-64ac-45be-b7c6-d20340730096immunoglobulin G, human 20 GM per 400 ML InjectionSY34These highlights do not include all the information needed to use FLEBOGAMMA 5% DIF safely and effectively. See full prescribing information for FLEBOGAMMA 5% DIF. FLEBOGAMMA 5% DIF (immune globulin intravenous [human]), solution for intravenous administration Initial U.S. Approval: 200620251117
6c3ce068-59f0-413b-9f93-85fb597d55e5immunoglobulin G, human 5 % per 400 ML InjectionSY26These 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
6c3ce068-59f0-413b-9f93-85fb597d55e5immunoglobulin G, human 5 % in 400 ML InjectionPSN26These 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
6c3ce068-59f0-413b-9f93-85fb597d55e5400 ML immunoglobulin G, human 50 MG/ML InjectionSCD26These 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
6c3ce068-59f0-413b-9f93-85fb597d55e5immunoglobulin G, human 20 GM per 400 ML InjectionSY26These 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