Fluzone High Dose Northern Hemisphere Injection, Suspension
NDC 63552-722

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 63552-722?
  4. Active Ingredients
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

Fluzone High Dose Northern Hemisphere (influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/croatia/10136/rv/2023 (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated)) is a BLA-approved product labeled by Patheon Manufacturing Services Llc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a injection, suspension for intramuscular administration. This product entry covers the primary NDC 63552-722 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
63552-722
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/croatia/10136/rv/2023 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)
Substance Name: [2]
Influenza A Virus A/croatia/10136rv/2023 X-425a (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
Code Navigator:

Clinical Specifications

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 & Regulatory Data

Labeler Name: [5]
Patheon Manufacturing Services Llc
Labeler Code:
63552
Product Label ID:
42c83754-08e6-5327-e063-6294a90a126e
FDA Application Number: [6]
BLA103914
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
09-01-2025
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 63552-722?

The NDC code 63552-722 is assigned by the FDA to the product Fluzone High Dose Northern Hemisphere. It is commonly known by its generic name, influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/croatia/10136/rv/2023 (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated). This pharmaceutical product is labeled by Patheon Manufacturing Services Llc and is currently categorized as listed product. The medication is a injection, suspension administered via intramuscular route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 63552-722-10. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are Active Ingredients of this product?

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 the associated UNII Codes?

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

  • INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: HQW9FZS4YK)
  • INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: SD82XNG5M6) (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)
  • 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)

Which are the Inactive Ingredients associated 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 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: 2709013 - influenza virus vaccine 2025 high dose (trivalent - Croatia/Victoria/Michigan) 0.5 mL Prefilled Syringe
  • RxCUI: 2709013 - 0.5 ML influenza A virus A/Croatia/10136RV/2023 (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: 2718469 - Fluzone 2025-2026 high-dose vaccine 0.5 ML Prefilled Syringe
  • RxCUI: 2718469 - 0.5 ML influenza A virus A/Croatia/10136RV/2023 (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 2025-2026]

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Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
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".