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)Disc2026-08-01
125077Flebogamma 5%, Flebogamma 5% DifImmune Globulin Intravenous (Human)351(a)Disc2026-08-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
2cf22c72-64ac-45be-b7c6-d20340730096immunoglobulin G, human 5 % in 400 ML Injection [PSN] · 400 ML immunoglobulin G, human 50 MG/ML Injection [SCD] · immunoglobulin G, human 20 GM per 400 ML Injection [SY] · immunoglobulin G, human 5 % per 400 ML Injection [SY]434These 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 % in 400 ML Injection [PSN] · 400 ML immunoglobulin G, human 50 MG/ML Injection [SCD] · immunoglobulin G, human 20 GM per 400 ML Injection [SY] · immunoglobulin G, human 5 % per 400 ML Injection [SY]426These 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