FDA.reportPublic FDA data

100 ML Gammagard ERC 100 MG/ML Injection

RxCUI
2733847
RxNorm name
100 ML Gammagard ERC 100 MG/ML Injection
Display name
100 ML Gammagard ERC 100 MG/ML Injection
Full name
100 ML Gammagard ERC 100 MG/ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:48

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
1341fd31-0754-47f0-a4d6-7255056b6541GAMMAGARD ERC 10 % in 100 ML Injection [PSN] · 100 ML immunoglobulin G, human 100 MG/ML Injection [Gammagard ERC] [SBD] · 100 ML Gammagard ERC 100 MG/ML Injection [SY] · Gammagard ERC 10 % per 100 ML Injection [SY] · Gammagard ERC 10 GM per 100 ML Injection [SY]52These highlights do not include all the information needed to use GAMMAGARD LIQUID ® ERC safely and effectively. See full prescribing information for GAMMAGARD LIQUID ERC. GAMMAGARD LIQUID ERC [immune globulin infusion (human)] 10% solution for intravenous, or subcutaneous use Initial U.S. Approval: 202520251030