NDC 60492-0173

CNJ-016

Vaccinia Immune Globulin (human)

CNJ-016 is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Emergent Biosolutions Canada Inc.. The primary component is Human Vaccinia Virus Immune Globulin.

Product ID60492-0173_3bb56e1d-118d-44b5-8768-fe1f47818977
NDC60492-0173
Product TypeHuman Prescription Drug
Proprietary NameCNJ-016
Generic NameVaccinia Immune Globulin (human)
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2005-05-01
Marketing CategoryBLA / BLA
Application NumberBLA125109
Labeler NameEmergent BioSolutions Canada Inc.
Substance NameHUMAN VACCINIA VIRUS IMMUNE GLOBULIN
Active Ingredient Strength1 [iU]/mL
Pharm ClassesHuman Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [EXT],Immunoglobulins [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 60492-0173-2

24 VIAL, SINGLE-USE in 1 CARTON (60492-0173-2) > 12 mL in 1 VIAL, SINGLE-USE (60492-0173-1)
Marketing Start Date2018-01-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60492-0173-1 [60492017301]

CNJ-016 INJECTION
Marketing CategoryBLA
Application NumberBLA125109
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-05-01

NDC 60492-0173-2 [60492017302]

CNJ-016 INJECTION
Marketing CategoryBLA
Application NumberBLA125109
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-12

Drug Details

Active Ingredients

IngredientStrength
HUMAN VACCINIA VIRUS IMMUNE GLOBULIN1 [iU]/mL

OpenFDA Data

SPL SET ID:a4f9f620-e6e4-4a03-a9a7-79007c8c2cfe
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1922334
  • 1922329
    • UPC Code
  • 0360492017321

    • Pharmacological Class

    • Human Immunoglobulin G [EPC]
    • Passively Acquired Immunity [PE]
    • Virus Neutralization [MoA]
    • Virus-specific Hyperimmune Globulins [EXT]
    • Immunoglobulins [CS]

    Trademark Results [CNJ-016]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CNJ-016
    CNJ-016
    78311014 3280400 Live/Registered
    EMERGENT BIOSOLUTIONS CANADA INC.
    2003-10-08
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.