FDA.reportPublic FDA data

10 ML immunoglobulin G, human 100 MG/ML Injection [Gamunex]

RxCUI
1809580
RxNorm name
10 ML immunoglobulin G, human 100 MG/ML Injection [Gamunex]
Display name
10 ML immunoglobulin G, human 100 MG/ML Injection [Gamunex]
Full name
10 ML immunoglobulin G, human 100 MG/ML Injection [Gamunex]
Term type
SBD
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
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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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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
ade6b84a-e95b-0a49-3296-f56208fdf35bgamunex-C 10 % in 10 mL Injection [PSN] · 10 ML immunoglobulin G, human 100 MG/ML Injection [Gamunex] [SBD] · 10 ML Gamunex 100 MG/ML Injection [SY] · Gamunex 10 % per 10 ML Injection [SY] · Gamunex-C 1 GM per 10 ML Injection [SY]537These 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