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  4. NDC Product Code: 49281-631 Fluzone Quadrivalent Northern Hemisphere

NDC 49281-631 Fluzone Quadrivalent Northern Hemisphere

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 49281-631?
  4. Fluzone Quadrivalent Northern Hemisphere Uses
  5. NDC to RxNorm Crosswalk
  6. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 49281-631 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
49281-631
Proprietary Name:
Fluzone Quadrivalent Northern Hemisphere
Product Type: [3]
Labeler Name: [5]
Sanofi Pasteur Inc.
Labeler Code:
49281
Product Label ID:
8213c229-a67a-4d3f-bd8f-b8729ae28472
FDA Application Number: [6]
BLA103914
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
07-01-2019
End Marketing Date: [10]
07-25-2024
Listing Expiration Date: [11]
07-25-2024
Exclude Flag: [12]
D
Code Navigator:

Code Structure Chart

Product Details

What is NDC 49281-631?

The NDC code 49281-631 is assigned by the FDA to the product Fluzone Quadrivalent Northern Hemisphere which is product labeled by Sanofi Pasteur Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 49281-631-15 1 vial, multi-dose in 1 package / 5 ml in 1 vial, multi-dose (49281-631-78). 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 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: 2709119 - influenza virus vaccine 2025 (quadrivalent - Croatia/Victoria/Michigan/Phuket) 0.5 ML Prefilled Syringe
  • RxCUI: 2709119 - 0.5 ML influenza A virus A/Croatia/10136RV/2023 (H3N2) antigen 0.03 MG/ML / influenza A virus A/Victoria/4897/2022 (H1N1) antigen 0.03 MG/ML / influenza B virus B/Michigan/01/2021 antigen 0.03 MG/ML / influenza B virus B/Phuket/3073/2013 antigen 0.03 MG/ML Prefilled Syringe
  • RxCUI: 2709125 - influenza virus vaccine 2025 (quadrivalent - Croatia/Victoria/Michigan/Phuket) Injectable Suspension
  • RxCUI: 2709125 - influenza A virus A/Croatia/10136RV/2023 (H3N2) antigen 0.03 MG/ML / influenza A virus A/Victoria/4897/2022 (H1N1) antigen 0.03 MG/ML / influenza B virus B/Michigan/01/2021 antigen 0.03 MG/ML / influenza B virus B/Phuket/3073/2013 antigen 0.03 MG/ML Injectable Suspension
  • RxCUI: 2719474 - Fluzone Quadrivalent 2025-2026 vaccine Injectable Suspension

* 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]


Flu Shot


Flu is a respiratory infection caused by a number of viruses. Most people with the flu get better on their own. But it can be serious. It can cause complications and sometimes even death. Getting the flu vaccine every year is the best way to lower your chance of getting the flu and spreading it to others.

The flu vaccine causes antibodies to develop in your body about two weeks after you get it. These antibodies provide protection against infection with the viruses that are in the vaccine.

There are different types of flu shots, including some especially for people 65 and older. Ask your health care provider which one is right for you.

Everyone 6 months of age and older should get a flu vaccine every season. People with egg allergies should check with their doctors before getting a vaccine. Other exceptions are people who have:

Centers for Disease Control and Prevention


[Learn More]


* Please review the disclaimer below.

Product Footnotes

[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.

[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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".