FDA.reportPublic FDA data

200 ML immunoglobulin G, human 50 MG/ML Injection

RxCUI
1809463
RxNorm name
200 ML immunoglobulin G, human 50 MG/ML Injection
Display name
200 ML immunoglobulin G, human 50 MG/ML Injection
Full name
200 ML immunoglobulin G, human 50 MG/ML Injection
Term type
SCD
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
125062OctagamImmune Globulin Intravenous (Human)351(a)Rx2026-09-01
125077Flebogamma 5%, Flebogamma 5% DifImmune Globulin Intravenous (Human)351(a)Disc2026-09-01
125329GammaplexImmune Globulin Intravenous (Human)351(a)Disc2026-09-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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No records found.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 4 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
2cf22c72-64ac-45be-b7c6-d20340730096immunoglobulin G, human 5 % in 200 ML Injection [PSN] · 200 ML immunoglobulin G, human 50 MG/ML Injection [SCD] · immunoglobulin G, human 10 GM per 200 ML Injection [SY] · immunoglobulin G, human 5 % per 200 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 200 ML Injection [PSN] · 200 ML immunoglobulin G, human 50 MG/ML Injection [SCD] · immunoglobulin G, human 10 GM per 200 ML Injection [SY] · immunoglobulin G, human 5 % per 200 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
de00abeb-d635-eddc-b603-10708ecef5aaimmunoglobulin G, human 5 % in 200 ML Injection [PSN] · 200 ML immunoglobulin G, human 50 MG/ML Injection [SCD] · immunoglobulin G, human 10 GM per 200 ML Injection [SY] · immunoglobulin G, human 5 % per 200 ML Injection [SY]411These highlights do not include all the information needed to use Octagam, Immune Globulin Intravenous (Human), safely and effectively. See full prescribing information for Octagam. Octagam [Immune Globulin Intravenous (Human)] 5% Liquid Preparation Initial U.S. Approval: 200420220419
fb07257b-e5e2-64c8-666c-65009f0aa604immunoglobulin G, human 5 % in 200 ML Injection [PSN] · 200 ML immunoglobulin G, human 50 MG/ML Injection [SCD] · immunoglobulin G, human 10 GM per 200 ML Injection [SY] · immunoglobulin G, human 5 % per 200 ML Injection [SY]43These highlights do not include all the information needed to use Octagam, Immune Globulin Intravenous (Human), safely and effectively. See full prescribing information for Octagam. Octagam [Immune Globulin Intravenous (Human)] 5% Liquid Preparation Initial U.S. Approval: 200420240129