FDA.reportPublic FDA data

immunoglobulin G, human 50 MG/ML Injection [Octagam]

RxCUI
1809644
RxNorm name
immunoglobulin G, human 50 MG/ML Injection [Octagam]
Display name
immunoglobulin G, human 50 MG/ML Injection [Octagam]
Full name
immunoglobulin G, human 50 MG/ML Injection [Octagam]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:06

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125062OctagamImmune Globulin Intravenous (Human)351(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 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
810c8752-a7cb-0bce-777d-8539429773c2immunoglobulin G, human 50 MG/ML Injection [Octagam] [SBD] · Octagam 50 MG/ML Injection [SY]24Octagam, Immune Globulin Intravenous (Human) 5% Liquid Preparation Initial U.S. Approval: 2004 - These highlights do not include all the information needed to use Octagam, Immune Globulin Intravenous (Human), safely and effectively. See full prescribing information for Octagam.20090909
c906fa75-6235-032a-284f-cd0b93794ff9immunoglobulin G, human 50 MG/ML Injection [Octagam] [SBD] · Octagam 50 MG/ML Injection [SY]21Octagam, Immune Globulin Intravenous (Human) 5% Liquid Preparation Initial U.S. Approval: 2004 - These highlights do not include all the information needed to use Octagam, Immune Globulin Intravenous (Human), safely and effectively. See full prescribing information for Octagam.20090909