Fluzone High-dose Quadrivalent with NDC 49281-120 is a a vaccine lable product labeled by Sanofi Pasteur Inc.. The generic name of Fluzone High-dose Quadrivalent is influenza a virus a/michigan/45/2015 x-275 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/singapore/infimh-16-0019/2016 ivr-186 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), and influenza b virus b/maryland/15/2016 bx-69a antigen (formaldehyde inactivated). The product's dosage form is injection, suspension and is administered via intramuscular form.
Labeler Name: Sanofi Pasteur Inc.
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.
Product Type: Vaccine 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.
Fluzone High-dose Quadrivalent Active Ingredient(s) What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
- INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) 60 ug/.7mL
- INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) 60 ug/.7mL
- INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED) 60 ug/.7mL
- INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED) 60 ug/.7mL
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
- Intramuscular - Administration within a muscle.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Labeler Name: Sanofi Pasteur Inc.
Labeler Code: 49281
FDA Application Number: BLA103914 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.
Marketing Category: BLA - A product marketed under an approved Biologic License Application. 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.
Start Marketing Date: 11-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date: 12-31-2020 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.
Exclude Flag: N 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. Values = ‘Y’ or ‘N’.
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