FDA.reportPublic FDA data

Octagam 10 GM per 200 ML Injection

RxCUI
1809649
RxNorm name
Octagam 10 GM per 200 ML Injection
Display name
Octagam 10 GM per 200 ML Injection
Full name
Octagam 10 GM per 200 ML Injection
Term type
SY
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 200 ML Injection [PSN] · 200 ML immunoglobulin G, human 50 MG/ML Injection [Octagam] [SBD] · 200 ML Octagam 50 MG/ML Injection [SY] · Octagam 10 GM per 200 ML Injection [SY] · Octagam 5 % per 200 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 200 ML Injection [PSN] · 200 ML immunoglobulin G, human 50 MG/ML Injection [Octagam] [SBD] · 200 ML Octagam 50 MG/ML Injection [SY] · Octagam 10 GM per 200 ML Injection [SY] · Octagam 5 % per 200 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