FDA.reportPublic FDA data

20 ML human vaccinia immune globulin 2500 UNT/ML Injection [CNJ-016]

RxCUI
1922334
RxNorm name
20 ML human vaccinia immune globulin 2500 UNT/ML Injection [CNJ-016]
Display name
20 ML human vaccinia immune globulin 2500 UNT/ML Injection [CNJ-016]
Full name
20 ML human vaccinia immune globulin 2500 UNT/ML Injection [CNJ-016]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:12

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125109Cnj-016Vaccinia 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
CNJ-016VACCINIA IMMUNE GLOBULIN INTRAVENOUS (HUMAN)Emergent BioSolutions Canada Inc.a4f9f620-e6e4-4a03-a9a7-79007c8c2cfe2025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1922334

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
a4f9f620-e6e4-4a03-a9a7-79007c8c2cfeCNJ-016 50,000 UNT in 20 ML Injection [PSN] · 20 ML human vaccinia immune globulin 2500 UNT/ML Injection [CNJ-016] [SBD] · 20 ML CNJ-016 2500 UNT/ML Injection [SY] · CNJ-016 50,000 UNT per 20 ML Injection [SY]48These highlights do not include all the information needed to use CNJ-016 ® (vaccinia immune globulin intravenous, human), VIGIV safely and effectively. See full prescribing information for VIGIV. VIGIV (vaccinia immune globulin, human), 5% solution for intravenous use. Initial U.S. Approval: 200520251216