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)Rx2026-06-01

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#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
de00abeb-d635-eddc-b603-10708ecef5aaOctagam 5 % per 50 ML InjectionSY11These 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
de00abeb-d635-eddc-b603-10708ecef5aaOctagam 2.5 GM per 50 ML InjectionSY11These 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
de00abeb-d635-eddc-b603-10708ecef5aaoctagam 5 % in 50 ML InjectionPSN11These 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
de00abeb-d635-eddc-b603-10708ecef5aa50 ML Octagam 50 MG/ML InjectionSY11These 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
de00abeb-d635-eddc-b603-10708ecef5aa50 ML immunoglobulin G, human 50 MG/ML Injection [Octagam]SBD11These 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-65009f0aa60450 ML Octagam 50 MG/ML InjectionSY3These 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
fb07257b-e5e2-64c8-666c-65009f0aa604octagam 5 % in 50 ML InjectionPSN3These 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
fb07257b-e5e2-64c8-666c-65009f0aa604Octagam 5 % per 50 ML InjectionSY3These 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
fb07257b-e5e2-64c8-666c-65009f0aa60450 ML immunoglobulin G, human 50 MG/ML Injection [Octagam]SBD3These 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
fb07257b-e5e2-64c8-666c-65009f0aa604Octagam 2.5 GM per 50 ML InjectionSY3These 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