FDA.reportPublic FDA data

200 ML immunoglobulin G, human 100 MG/ML Injection [Gammaked]

RxCUI
1809445
RxNorm name
200 ML immunoglobulin G, human 100 MG/ML Injection [Gammaked]
Display name
200 ML immunoglobulin G, human 100 MG/ML Injection [Gammaked]
Full name
200 ML immunoglobulin G, human 100 MG/ML Injection [Gammaked]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:07

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125046Gammaked, Gamunex-CImmune Globulin Injection (Human) 10% Caprylate/Chromatography Purified351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

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UNII Substances#

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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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
8c004331-7a91-8046-7510-9b9b7d33ced7gammaked 10 % in 200 ML Injection [PSN] · 200 ML immunoglobulin G, human 100 MG/ML Injection [Gammaked] [SBD] · 200 ML Gammaked 100 MG/ML Injection [SY] · Gammaked 10 % per 200 ML Injection [SY] · Gammaked 20 GM per 200 ML Injection [SY]534These highlights do not include all the information needed to use GAMMAKED™ safely and effectively. See full prescribing information for GAMMAKED. GAMMAKED™, [Immune Globulin Injection (Human), 10% Caprylate/ Chromatography Purified] Initial U.S. Approval: 200320200114