Flublok Quadrivalent Northern Hemisphere
NDC 49281-722
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
Flublok Quadrivalent Northern Hemisphere is a BLA-approved product labeled by Sanofi Pasteur Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 49281-722 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
49281-722
Proprietary Name:
Flublok Quadrivalent Northern Hemisphere
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
49281
Product Label ID:
FDA Application Number: [6]
BLA125285
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Marketing Timeline
Start Marketing Date: [9]
07-01-2022
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
I
Code Structure Chart
Product Details
What is NDC 49281-722?
The NDC code 49281-722 is assigned by the FDA to the product Flublok Quadrivalent Northern Hemisphere. This pharmaceutical product is labeled by Sanofi Pasteur Inc. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 49281-722-10. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
Flublok Quadrivalent is a vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Flublok Quadrivalent is approved for use in persons 18 years of age and older [see Clinical Studies (14)].
What is the NDC to RxNorm Crosswalk for this product?
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: 2605564 - influenza virus vaccine 2022-2023 (quadrivalent - Darwin/Wisconsin/Austria/Phuket) 0.5 ML Prefilled Syringe
- RxCUI: 2605564 - 0.5 ML influenza A virus A/Darwin/6/2021 (H3N2) antigen 0.09 MG/ML / influenza A virus A/Wisconsin/588/2019 (H1N1) antigen 0.09 MG/ML / influenza B virus B/Austria/1359417/2021 antigen 0.09 MG/ML / influenza B virus B/Phuket/3073/2013 antigen 0.09 MG/ML Prefilled Syringe
- RxCUI: 2605570 - FLUBLOK Quadrivalent 2022-2023 vaccine 0.5 ML Prefilled Syringe
- RxCUI: 2605570 - 0.5 ML influenza A virus A/Darwin/6/2021 (H3N2) antigen 0.09 MG/ML / influenza A virus A/Wisconsin/588/2019 (H1N1) antigen 0.09 MG/ML / influenza B virus B/Austria/1359417/2021 antigen 0.09 MG/ML / influenza B virus B/Phuket/3073/2013 antigen 0.09 MG/ML Prefilled Syringe [Flublok Quadrivalent 2022-2023]
- RxCUI: 2605570 - Flublok Quadrivalent 2022-2023 vaccine 0.5 ML Prefilled Syringe
* Please review the full disclaimer at the bottom of this page.
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 full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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".
