FDA.reportPublic FDA data

GAMMAGARD 10 GM Injection

RxCUI
1809738
RxNorm name
GAMMAGARD 10 GM Injection
Display name
GAMMAGARD 10 GM Injection
Full name
GAMMAGARD 10 GM Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:19

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103133Gammagard, Gammagard S/D, IveegamImmune Globulin Intravenous (Human)351(a)Disc2026-09-01

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.

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
bf8df9fd-bfdd-47c2-84d2-d91e50947bf6GAMMAGARD 10 GM Injection [PSN] · immunoglobulin G, human 10000 MG Injection [Gammagard] [SBD] · Gammagard 10 GM Injection [SY] · Gammagard 10000 MG Injection [SY]412These highlights do not include all the information needed to use GAMMAGARD S/D safely and effectively. See full prescribing information for GAMMAGARD S/D GAMMAGARD ® S/D, Immune Globulin Intravenous (Human) IgA less than 1 microgram per mL in a 5% Solution Initial U.S. Approval: 199420251125