FDA.reportPublic FDA data

CNJ-016

Product NDC
60492-0173
Requested package NDC
60492-0173-2
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
IngredientStrength
HUMAN VACCINIA VIRUS IMMUNE GLOBULIN1 [iU]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7UB4J759TDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1922329Internal RxNorm lookup
1922334Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a4f9f620-e6e4-4a03-a9a7-79007c8c2cfeAvailable on FDA.report

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 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

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

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
application number: BLA125109
ndc (package): 60492-0173-2
ndc (product): 60492-0173
ndc11 (package): 60492017302

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1922334CNJ-016 50,000 UNT in 20 ML InjectionPSNa4f9f620-e6e4-4a03-a9a7-79007c8c2cfe8
1922329Human vaccinia immune globulin 50,000 UNT in 20 ML InjectionPSNa4f9f620-e6e4-4a03-a9a7-79007c8c2cfe8
192233420 ML human vaccinia immune globulin 2500 UNT/ML Injection [CNJ-016]SBDa4f9f620-e6e4-4a03-a9a7-79007c8c2cfe8
192232920 ML human vaccinia immune globulin 2500 UNT/ML InjectionSCDa4f9f620-e6e4-4a03-a9a7-79007c8c2cfe8
192233420 ML CNJ-016 2500 UNT/ML InjectionSYa4f9f620-e6e4-4a03-a9a7-79007c8c2cfe8
1922334CNJ-016 50,000 UNT per 20 ML InjectionSYa4f9f620-e6e4-4a03-a9a7-79007c8c2cfe8
1922329Human vaccinia immune globulin 50,000 UNT per 20 ML InjectionSYa4f9f620-e6e4-4a03-a9a7-79007c8c2cfe8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60492-0173-26049201730224 VIAL, SINGLE-USE in 1 CARTON (60492-0173-2) / 12 mL in 1 VIAL, SINGLE-USE (60492-0173-1) 2018-01-120000-00-00NoNoCurrent