FDA.reportPublic FDA data

NDC 60492-0173-1 - CNJ-016

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
60492-0173
Requested NDC
60492-0173-1
Package NDCs from labels
60492-0173-1, 60492-0173-2
Manufacturer
Emergent BioSolutions Canada Inc.
Effective date
2025-12-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CNJ-016 - Emergent BioSolutions Canada Inc.Emergent BioSolutions Canada Inc.2025-12-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60492-0173-1CNJ-01612 mL in 1 VIAL, SINGLE-USEINJECTION128
60492-0173-2CNJ-01624 in 1 CARTONINJECTION248

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60492-0173CNJ-016 (VACCINIA IMMUNE GLOBULIN (HUMAN)) INJECTION [EMERGENT BIOSOLUTIONS CANADA INC.]6Current NDC, Legacy NDC, 2 package rows20190522_a4f9f620-e6e4-4a03-a9a7-79007c8c2cfe.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60492-0173-1EA - Each60492-01735bb3db26-44c1-4a96-969a-13a4598ec23c12022-10-06
60492-0173-2EA - Each60492-01731f78cef1-05ba-4df4-aa26-904ca752adca12022-10-06

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 ยท 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
unii: 6OZP39ZG8H
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: 6OZP39ZG8H
CNJ-016VACCINIA IMMUNE GLOBULIN INTRAVENOUS (HUMAN)Emergent BioSolutions Canada Inc.a4f9f620-e6e4-4a03-a9a7-79007c8c2cfe2025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125109
ndc (package): 60492-0173-1
ndc (package): 60492-0173-2
ndc (product): 60492-0173
ndc11 (package): 60492017301
rxcui: 1922334
rxcui: 1922329
spl id: ad4abcf6-88ca-41ff-a0f0-75692c8d517c
spl set id: a4f9f620-e6e4-4a03-a9a7-79007c8c2cfe
unii: 7UB4J759TD
Refresh Digital PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.97e83e68-6374-4df4-93f6-d707fc32748d2022-11-28WarningsExact identifier
unii: 6OZP39ZG8H
Refresh DigitalCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.b2bd34d4-fab9-4f4b-9be2-5d30b55f5b812022-11-28WarningsExact identifier
unii: 6OZP39ZG8H
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
unii: 6OZP39ZG8H
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
unii: 6OZP39ZG8H
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: 6OZP39ZG8H

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.