FDA.reportPublic FDA data

25 ML immunoglobulin G, human 100 MG/ML Injection

RxCUI
1809438
RxNorm name
25 ML immunoglobulin G, human 100 MG/ML Injection
Display name
25 ML immunoglobulin G, human 100 MG/ML Injection
Full name
25 ML immunoglobulin G, human 100 MG/ML Injection
Term type
SCD
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
125105Gammagard LiquidImmune Globulin Infusion (Human)351(a)Rx2026-09-01
125402HyqviaImmune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase351(a)Rx2026-09-01
125046Gammaked, Gamunex-CImmune Globulin Injection (Human) 10% Caprylate/Chromatography Purified351(a)Rx2026-09-01

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 · 4 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
ade6b84a-e95b-0a49-3296-f56208fdf35bimmunoglobulin G, human 10 % in 25 ML Injection [PSN] · 25 ML immunoglobulin G, human 100 MG/ML Injection [SCD] · immunoglobulin G, human 10 % per 25 ML Injection [SY] · immunoglobulin G, human 2.5 GM per 25 ML Injection [SY]437These 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
8c004331-7a91-8046-7510-9b9b7d33ced7immunoglobulin G, human 10 % in 25 ML Injection [PSN] · 25 ML immunoglobulin G, human 100 MG/ML Injection [SCD] · immunoglobulin G, human 10 % per 25 ML Injection [SY] · immunoglobulin G, human 2.5 GM per 25 ML Injection [SY]434These 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
7ca2c26f-4be2-48cd-be5b-486e350654baimmunoglobulin G, human 10 % in 25 ML Injection [PSN] · 25 ML immunoglobulin G, human 100 MG/ML Injection [SCD] · immunoglobulin G, human 10 % per 25 ML Injection [SY] · immunoglobulin G, human 2.5 GM per 25 ML Injection [SY]422These highlights do not include all the information needed to use HYQVIA ® safely and effectively. See full prescribing information for HYQVIA. HYQVIA ® [Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase] Solution, for subcutaneous administration Initial U.S. Approval: 201420260204
9d42adca-0dd7-4df7-864d-5a7feee52130immunoglobulin G, human 10 % in 25 ML Injection [PSN] · 25 ML immunoglobulin G, human 100 MG/ML Injection [SCD] · immunoglobulin G, human 10 % per 25 ML Injection [SY] · immunoglobulin G, human 2.5 GM per 25 ML Injection [SY]422These 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