Home NDC 60492-0173 CNJ-016
Product NDC 60492-0173
11-digit product format 604920173
Labeler code 60492
Product ID 60492-0173_ad4abcf6-88ca-41ff-a0f0-75692c8d517c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Vaccinia Immune Globulin Intravenous (Human)
Dosage form INJECTION
Route INTRAVENOUS
Labeler Emergent BioSolutions Canada Inc.
Application BLA125109
Marketing category BLA
Marketing start 2005-05-02
Substance HUMAN VACCINIA VIRUS IMMUNE GLOBULIN
Active strength 1 [iU]/mL
Pharmacologic classes Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base CNJ-016
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HUMAN VACCINIA VIRUS IMMUNE GLOBULIN 1 [iU]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7UB4J759TD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1922329 Internal RxNorm lookup 1922334 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60492-0173-1 CNJ-016 12 mL in 1 VIAL, SINGLE-USE INJECTION 12 8 60492-0173-2 CNJ-016 24 in 1 CARTON INJECTION 24 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60492-0173 CNJ-016 (VACCINIA IMMUNE GLOBULIN (HUMAN)) INJECTION [EMERGENT BIOSOLUTIONS CANADA INC.] 6 Current NDC, Legacy NDC, 2 package rows 20190522_a4f9f620-e6e4-4a03-a9a7-79007c8c2cfe.zip
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CNJ-016 VACCINIA IMMUNE GLOBULIN INTRAVENOUS (HUMAN) Emergent BioSolutions Canada Inc. a4f9f620-e6e4-4a03-a9a7-79007c8c2cfe 2025-12-16 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125109 ndc (product): 60492-0173
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125109 Cnj-016 Vaccinia Immune Globulin Intravenous (Human) 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60492-0173-1 60492017301 12 mL in 1 VIAL, SINGLE-USE 12 ml Historical 60492-0173-2 60492017302 24 VIAL, SINGLE-USE in 1 CARTON (60492-0173-2) / 12 mL in 1 VIAL, SINGLE-USE (60492-0173-1) 2018-01-12 0000-00-00 No No Current