1. Home
  2. Labeler Index
  3. Sanofi Pasteur Inc.
  4. NDC Product Code: 49281-467 Fluzone High Dose Northern Hemisphere

NDC 49281-467 Fluzone High Dose Northern Hemisphere

Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 49281-467?
  4. Fluzone High Dose Northern Hemisphere Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
49281-467
Proprietary Name:
Fluzone High Dose Northern Hemisphere
Non-Proprietary Name: [1]
Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)
Substance Name: [2]
Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated); Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated); Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)
NDC Directory Status:
Vaccine
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route(s): [4]
  • Intramuscular - Administration within a muscle.
    • Labeler Name: [5]
    Sanofi Pasteur Inc.
    Labeler Code:
    49281
    Product Label ID:
    de0e2089-f781-4d47-99f5-c2a1b7b0f1eb
    FDA Application Number: [6]
    BLA103914
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    03-04-2024
    End Marketing Date: [10]
    06-30-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 49281-467?

    The NDC code 49281-467 is assigned by the FDA to the product Fluzone High Dose Northern Hemisphere which is a vaccine label product labeled by Sanofi Pasteur Inc.. The generic name of Fluzone High Dose Northern Hemisphere is influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/darwin/9/2021 san-010 (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated). The product's dosage form is injection, suspension and is administered via intramuscular form. The product is distributed in a single package with assigned NDC code 49281-467-65 5 syringe, glass in 1 package / .5 ml in 1 syringe, glass (49281-467-88). 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 Fluzone High Dose Northern Hemisphere?

    Fluzone® High-Dose is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine.Fluzone High-Dose is approved for use in persons 65 years of age and older.

    What are Fluzone High Dose Northern Hemisphere 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 Fluzone High Dose Northern Hemisphere UNII Codes?

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

    • INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: AU5C98U4BB)
    • INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: C46XJT9FQ9) (Active Moiety)
    • INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: KJA387FHB2)
    • INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 6S4Y8A8UEY) (Active Moiety)
    • INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: FF9YP4D23C)
    • INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: CQV855H5FG) (Active Moiety)

    Which are Fluzone High Dose Northern Hemisphere 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 Fluzone High Dose Northern Hemisphere?

    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: 2677170 - influenza virus vaccine 2023-2024 high-dose (Darwin/Victoria/Michigan) Prefilled Syringe 0.5 ML
    • RxCUI: 2677170 - 0.5 ML influenza A virus A/Darwin/9/2021 (H3N2) antigen 0.12 MG/ML / influenza A virus A/Victoria/4897/2022 (H1N1) antigen 0.12 MG/ML / influenza B virus B/Michigan/01/2021 antigen 0.12 MG/ML Prefilled Syringe
    • RxCUI: 2677177 - Fluzone 2023-2024 high-dose vaccine 0.5 ML Prefilled Syringe
    • RxCUI: 2677177 - 0.5 ML influenza A virus A/Darwin/9/2021 (H3N2) antigen 0.12 MG/ML / influenza A virus A/Victoria/4897/2022 (H1N1) antigen 0.12 MG/ML / influenza B virus B/Michigan/01/2021 antigen 0.12 MG/ML Prefilled Syringe [Fluzone 2023-2024]

    * 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.

    [10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

    [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".