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  4. NDC Product Code: 60492-0173 Cnj-016

NDC 60492-0173 Cnj-016

Vaccinia Immune Globulin (human) Injection Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 60492-0173?
  4. Cnj-016 Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes

Product Information

NDC Product Code:
60492-0173
Proprietary Name:
Cnj-016
Non-Proprietary Name: [1]
Vaccinia Immune Globulin (human)
Substance Name: [2]
Human Vaccinia Virus Immune Globulin
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
    • Labeler Name: [5]
    Emergent Biosolutions Canada Inc.
    Labeler Code:
    60492
    Product Label ID:
    a4f9f620-e6e4-4a03-a9a7-79007c8c2cfe
    FDA Application Number: [6]
    BLA125109
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    05-01-2005
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 60492-0173-2

    Package Description: 24 VIAL, SINGLE-USE in 1 CARTON / 12 mL in 1 VIAL, SINGLE-USE (60492-0173-1)

    Product Details

    What is NDC 60492-0173?

    The NDC code 60492-0173 is assigned by the FDA to the product Cnj-016 which is a human prescription drug product labeled by Emergent Biosolutions Canada Inc.. The generic name of Cnj-016 is vaccinia immune globulin (human). The product's dosage form is injection and is administered via intravenous form. The product is distributed in a single package with assigned NDC code 60492-0173-2 24 vial, single-use in 1 carton / 12 ml in 1 vial, single-use (60492-0173-1). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Cnj-016?

    CNJ-016® [Vaccinia Immune Globulin Intravenous (Human)] (VIGIV) is indicated for the treatment and/or modification of the following conditions:•Eczema vaccinatum•Progressive vaccinia•Severe generalized vaccinia•Vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy; or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions•Aberrant infections induced by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard.Exercise caution when using VIGIV in the treatment of patients having complication due to vaccinia vaccination that include concomitant vaccinia keratitis, since a single study in rabbits has demonstrated increased corneal scarring upon intramuscular vaccinia immune globulin administration in vaccinia keratitis (1).VIGIV is not considered to be effective in the treatment of postvaccinial encephalitis.

    What are Cnj-016 Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Cnj-016 UNII Codes?

    The UNII codes for the active ingredients in this product are:

    • HUMAN VACCINIA VIRUS IMMUNE GLOBULIN (UNII: 7UB4J759TD)
    • HUMAN VACCINIA VIRUS IMMUNE GLOBULIN (UNII: 7UB4J759TD) (Active Moiety)

    Which are Cnj-016 Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Cnj-016?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 1922329 - Human vaccinia immune globulin 50,000 UNT in 20 ML Injection
    • RxCUI: 1922329 - 20 ML human vaccinia immune globulin 2500 UNT/ML Injection
    • RxCUI: 1922329 - Human vaccinia immune globulin 50,000 UNT per 20 ML Injection
    • RxCUI: 1922334 - CNJ-016 50,000 UNT in 20 ML Injection
    • RxCUI: 1922334 - 20 ML human vaccinia immune globulin 2500 UNT/ML Injection [CNJ-016]

    Which are the Pharmacologic Classes for Cnj-016?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".