NDC 49281-421 Fluzone Quadrivalent Northern Hemisphere

Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
49281-421
Proprietary Name:
Fluzone Quadrivalent Northern Hemisphere
Non-Proprietary Name: [1]
Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/tasmania/503/2020 Ivr-221 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated)
Substance Name: [2]
Influenza A Virus A/tasmania/503/2020 Ivr-221 (h3n2) Antigen (formaldehyde Inactivated); Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated); Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated); Influenza B Virus B/washington/02/2019 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
    FDA Application Number: [6]
    BLA103914
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    07-02-2021
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 49281-421-10

    Package Description: 10 VIAL, SINGLE-DOSE in 1 PACKAGE / .5 mL in 1 VIAL, SINGLE-DOSE (49281-421-58)

    NDC Code 49281-421-50

    Package Description: 10 SYRINGE, GLASS in 1 PACKAGE / .5 mL in 1 SYRINGE, GLASS (49281-421-88)

    Product Details

    What is NDC 49281-421?

    The NDC code 49281-421 is assigned by the FDA to the product Fluzone Quadrivalent Northern Hemisphere which is a vaccine label product labeled by Sanofi Pasteur Inc.. The generic name of Fluzone Quadrivalent Northern Hemisphere is influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/tasmania/503/2020 ivr-221 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), influenza b virus b/washington/02/2019 antigen (formaldehyde inactivated). The product's dosage form is injection, suspension and is administered via intramuscular form. The product is distributed in 2 packages with assigned NDC codes 49281-421-10 10 vial, single-dose in 1 package / .5 ml in 1 vial, single-dose (49281-421-58), 49281-421-50 10 syringe, glass in 1 package / .5 ml in 1 syringe, glass (49281-421-88). 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 Quadrivalent Northern Hemisphere?

    Fluzone® Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.Fluzone Quadrivalent is approved for use in persons 6 months of age and older.

    What are Fluzone Quadrivalent 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.

    What is the NDC to RxNorm Crosswalk for Fluzone Quadrivalent 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: 2050785 - influenza A virus A/Michigan/45/2015 (H1N1) antigen 0.03 MG/ML / influenza A virus A/Singapore/INFIMH-16-0019/2016 (H3N2) antigen 0.03 MG/ML / influenza B virus B/Maryland/15/2016 antigen 0.03 MG/ML / influenza B virus B/Phuket/3073/2013 antigen 0.03 MG/ML Injectable Suspension
    • RxCUI: 2050787 - Fluzone Quadrivalent 2018-2019 vaccine Injectable Suspension
    • RxCUI: 2050787 - influenza A virus A/Michigan/45/2015 (H1N1) antigen 0.03 MG/ML / influenza A virus A/Singapore/INFIMH-16-0019/2016 (H3N2) antigen 0.03 MG/ML / influenza B virus B/Maryland/15/2016 antigen 0.03 MG/ML / influenza B virus B/Phuket/3073/2013 antigen 0.03 MG/ML Injectable Suspension [Fluzone Quadrivalent 2018-2019]
    • RxCUI: 2177503 - influenza virus vaccine 2019-2020 (quadrivalent - Brisbane/Kansas/Maryland/Phuket) 0.25 mL Prefilled Syringe
    • RxCUI: 2177503 - 0.25 ML influenza A virus A/Brisbane/02/2018 (H1N1) antigen 0.03 MG/ML / influenza A virus A/Kansas/14/2017 (H3N2) antigen 0.03 MG/ML / influenza B virus B/Maryland/15/2016 antigen 0.03 MG/ML / influenza B virus B/Phuket/3073/2013 antigen 0.03 MG/ML Prefilled Syringe

    * Please review the disclaimer below.

    Patient Education

    Influenza Vaccine, Inactivated or Recombinant


    Why get vaccinated? Influenza vaccine can prevent influenza (flu). Flu is a contagious disease that spreads around the United States every year, usually between October and May. Anyone can get the flu, but it is more dangerous for some people. Infants and young children, people 65 years of age and older, pregnant people, and people with certain health conditions or a weakened immune system are at greatest risk of flu complications. Pneumonia, bronchitis, sinus infections and ear infections are examples of flu-related complications. If you have a medical condition, such as heart disease, cancer or diabetes, flu can make it worse. Flu can cause fever and chills, sore throat, muscle aches, fatigue, cough, headache, and runny or stuffy nose. Some people may have vomiting and diarrhea, though this is more common in children than adults. Each year thousands of people in the United States die from flu, and many more are hospitalized. Flu vaccine prevents millions of illnesses and flu-related visits to the doctor each year.
    [Learn More]


    * 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".