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)Rx2026-08-01

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.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BIVIGAMIMMUNE GLOBULIN INTRAVENOUS (HUMAN) 10%ADMA Biologics, Inc.a2244aa0-a6d0-11df-b385-0002a5d5c51b2025-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1809416

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