FDA.reportPublic FDA data

GAMMAGARD 10 % in 10 ML Injection

RxCUI
1809665
RxNorm name
GAMMAGARD 10 % in 10 ML Injection
Display name
GAMMAGARD 10 % in 10 ML Injection
Full name
GAMMAGARD 10 % in 10 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:10

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125105Gammagard LiquidImmune Globulin Infusion (Human)351(a)Rx2026-08-01

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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
9d42adca-0dd7-4df7-864d-5a7feee52130GAMMAGARD 10 % in 10 ML Injection [PSN] · 10 ML immunoglobulin G, human 100 MG/ML Injection [Gammagard] [SBD] · 10 ML Gammagard 100 MG/ML Injection [SY] · Gammagard 1 GM per 10 ML Injection [SY] · Gammagard 10 % per 10 ML Injection [SY]522These highlights do not include all the information needed to use GAMMAGARD LIQUID ® safely and effectively. See full prescribing information for GAMMAGARD LIQUID. GAMMAGARD LIQUID ® , Immune Globulin Infusion (Human), 10% Solution, for intravenous and subcutaneous administration Initial U.S. Approval: 200520251210