FDA.reportPublic FDA data

Bivigam 5 GM per 50 ML Injection

RxCUI
1809416
RxNorm name
Bivigam 5 GM per 50 ML Injection
Display name
Bivigam 5 GM per 50 ML Injection
Full name
Bivigam 5 GM per 50 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:11

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125389BivigamImmune Globulin Intravenous (Human)351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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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
a2244aa0-a6d0-11df-b385-0002a5d5c51bBivigam 10 % in 50 ML Injection [PSN] · 50 ML immunoglobulin G, human 100 MG/ML Injection [Bivigam] [SBD] · 50 ML Bivigam 100 MG/ML Injection [SY] · Bivigam 10 % per 50 ML Injection [SY] · Bivigam 5 GM per 50 ML Injection [SY]515These highlights do not include all the information needed to use BIVIGAM ® safely and effectively. See full prescribing information for BIVIGAM. Immune Globulin Intravenous (Human), 10% Liquid BIVIGAM Initial U.S. Approval : 201220250505
00dd9bbb-ee8b-f369-8cd1-6ce28925f118Bivigam 10 % in 50 ML Injection [PSN] · 50 ML immunoglobulin G, human 100 MG/ML Injection [Bivigam] [SBD] · 50 ML Bivigam 100 MG/ML Injection [SY] · Bivigam 10 % per 50 ML Injection [SY] · Bivigam 5 GM per 50 ML Injection [SY]52These highlights do not include all the information needed to use BIVIGAM safely and effectively. See full prescribing information for BIVIGAM. Immune Globulin Intravenous (Human), 10% Liquid BIVIGAM Initial U.S. Approval : 201220160225