Fluzone High Dose Northern Hemisphere Injection, Suspension
NDC Package 63552-722-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package 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)) injection is a vaccine administered via intramuscular route. This formulation utilizes a injection, suspension delivery system. Marketed by Patheon Manufacturing Services Llc, this product is identified by NDC 63552-722 and is authorized under FDA application BLA103914.

Identification & Billing

NDC Package Code
63552-722-10
Package Description
5 SYRINGE, GLASS in 1 PACKAGE / .5 mL in 1 SYRINGE, GLASS (63552-722-05)
Product Code
63552-722
11-Digit Billing Format
63552072210
RxNorm Crosswalk
  • 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]

Clinical Specifications

Proprietary Name
Fluzone High Dose Northern Hemisphere
Non-Proprietary 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)
Substance Name
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)
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
Intramuscular - Administration within a muscle.
Active Ingredient(s)

Regulatory & Marketing

Labeler Name
Patheon Manufacturing Services Llc
Product Type
Vaccine
FDA Application #
BLA103914
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
09-01-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 63552-722-10 identifies a specific commercial package of 5 syringe, glass in 1 package / .5 ml in 1 syringe, glass (63552-722-05) of Fluzone High Dose Northern Hemisphere, a vaccine label labeled by Patheon Manufacturing Services Llc. This injection, suspension is formulated for intramuscular use and contains 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) as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Patheon Manufacturing Services Llc on September 01, 2025. The current certification is valid through December 31, 2026.

How is this Patheon Manufacturing Services Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63552072210. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
63552-722-10
11-Digit CMS (5-4-2)
63552-0722-10

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.