FDA.reportPublic FDA data

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

RxCUI
1809647
RxNorm name
50 ML immunoglobulin G, human 50 MG/ML Injection [Octagam]
Display name
50 ML immunoglobulin G, human 50 MG/ML Injection [Octagam]
Full name
50 ML immunoglobulin G, human 50 MG/ML Injection [Octagam]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:24

Purple Book Biologic Products#

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

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
de00abeb-d635-eddc-b603-10708ecef5aaoctagam 5 % in 50 ML Injection [PSN] · 50 ML immunoglobulin G, human 50 MG/ML Injection [Octagam] [SBD] · 50 ML Octagam 50 MG/ML Injection [SY] · Octagam 2.5 GM per 50 ML Injection [SY] · Octagam 5 % per 50 ML Injection [SY]511These highlights do not include all the information needed to use Octagam, Immune Globulin Intravenous (Human), safely and effectively. See full prescribing information for Octagam. Octagam [Immune Globulin Intravenous (Human)] 5% Liquid Preparation Initial U.S. Approval: 200420220419
fb07257b-e5e2-64c8-666c-65009f0aa604octagam 5 % in 50 ML Injection [PSN] · 50 ML immunoglobulin G, human 50 MG/ML Injection [Octagam] [SBD] · 50 ML Octagam 50 MG/ML Injection [SY] · Octagam 2.5 GM per 50 ML Injection [SY] · Octagam 5 % per 50 ML Injection [SY]53These highlights do not include all the information needed to use Octagam, Immune Globulin Intravenous (Human), safely and effectively. See full prescribing information for Octagam. Octagam [Immune Globulin Intravenous (Human)] 5% Liquid Preparation Initial U.S. Approval: 200420240129