FDA.reportPublic FDA data

immunoglobulin G, human 10 % in 300 ML Injection

RxCUI
1809539
RxNorm name
immunoglobulin G, human 10 % in 300 ML Injection
Display name
immunoglobulin G, human 10 % in 300 ML Injection
Full name
immunoglobulin G, human 10 % in 300 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)Rx2026-09-01
125062OctagamImmune Globulin Intravenous (Human)351(a)Rx2026-09-01
125402HyqviaImmune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase351(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
7ca2c26f-4be2-48cd-be5b-486e350654baimmunoglobulin G, human 10 % in 300 ML Injection [PSN] · 300 ML immunoglobulin G, human 100 MG/ML Injection [SCD] · immunoglobulin G, human 10 % per 300 ML Injection [SY]322These 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 300 ML Injection [PSN] · 300 ML immunoglobulin G, human 100 MG/ML Injection [SCD] · immunoglobulin G, human 10 % per 300 ML Injection [SY]322These 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
a36a12dc-16be-b135-466f-393954f428a7immunoglobulin G, human 10 % in 300 ML Injection [PSN] · 300 ML immunoglobulin G, human 100 MG/ML Injection [SCD] · immunoglobulin G, human 10 % per 300 ML Injection [SY]321These highlights do not include all the information needed to use Octagam 10% safely and effectively. See full prescribing information for Octagam 10%. Octagam 10% [Immune Globulin Intravenous (Human)] liquid solution for intravenous administration Initial U.S. Approval: 201420220408
eb4c342b-122c-0072-1428-1747882e6c00immunoglobulin G, human 10 % in 300 ML Injection [PSN] · 300 ML immunoglobulin G, human 100 MG/ML Injection [SCD] · immunoglobulin G, human 10 % per 300 ML Injection [SY]32These highlights do not include all the information needed to use Octagam 10% safely and effectively. See full prescribing information for Octagam 10%. Octagam 10% [Immune Globulin Intravenous (Human)] liquid solution for intravenous administration Initial U.S. Approval: 201420240126