FDA.reportPublic FDA data

botulism immune globulin IV human 100 MG Injection

RxCUI
544491
RxNorm name
botulism immune globulin IV human 100 MG Injection
Display name
botulism immune globulin IV human 100 MG Injection
Full name
botulism immune globulin IV human 100 MG Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:10

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125034BabyBigBotulism Immune Globulin Intravenous (Human)351(a)Rx2026-09-01

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
BabyBIGHUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULINCALIFORNIA DEPARTMENT OF PUBLIC HEALTH9ec59262-35c1-4d8e-8451-a7cfbacb06752025-12-08Warnings, Adverse reactionsExact identifier
rxcui: 544491

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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
9ec59262-35c1-4d8e-8451-a7cfbacb0675botulism immune globulin, human 100 MG Injection [PSN] · botulism immune globulin IV human 100 MG Injection [SCD] · botulism immune globulin, human 100 MG Injection [SY]314These highlights do not include all the information needed to use BabyBIG, [Botulism Immune Globulin Intravenous (Human)], safely and effectively. See full prescribing information for BabyBIG. BabyBIG [Botulism Immune Globulin Intravenous (Human) (BIG-IV)] Lyophilized Powder for Reconstitution and Injection Initial U.S. Approval: 200320251208