Fluzone High Dose Northern Hemisphere NDC 63552-722

Product information

Brand name (proprietary)

Fluzone High Dose Northern Hemisphere

Generic name (nonproprietary)

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)

Active ingredients

Influenza a virus a/croatia/10136rv/2023 x-425a (H3n2) antigen (Formaldehyde inactivated) — 60 ug/.5mLInfluenza b virus b/michigan/01/2021 antigen (Formaldehyde inactivated) — 60 ug/.5mLInfluenza a virus a/victoria/4897/2022 ivr-238 (H1n1) antigen (Formaldehyde inactivated) — 60 ug/.5mL

Dosage form

Injection, Suspension

Route

Intramuscular

Labeler

Patheon Manufacturing Services LLCNDC labeler code 63552

Product type

Vaccine

Marketing category

BLA — Biologics License ApplicationApplication BLA 103914

Marketing start

Sep 1, 2025

Listing expires

Dec 31, 2026

Identifiers

Product ID 63552-722_42c83754-08e7-5327-e063-6294a90a126eSPL ID 42c83754-08e7-5327-e063-6294a90a126e

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Immunization administration (CPT 90460–90474)

Giving a vaccine is reported separately from the vaccine product code, with an immunization administration code. Which code applies depends on the patient's age, the route and whether counselling was provided.

How CPT relates to drug billing

NDC on a medical claim

N463552072210 followed by a unit qualifier and the quantity Copy

Package 63552-0722-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

The FDA listing for this product does not reference a label (SPL) set.

About NDC 63552-722

What is NDC 63552-722?

63552-722 is the product NDC for Fluzone High Dose Northern Hemisphere, Influenza a virus a/croatia/10136rv/2023 x-425a (H3n2) antigen (Formaldehyde inactivated) 60 ug/.5mL + 2 more ingredients injection, suspension, listed with the FDA by Patheon Manufacturing Services LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

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)).

What is the active ingredient?

Influenza a virus a/croatia/10136rv/2023 x-425a (H3n2) antigen (Formaldehyde inactivated), Influenza b virus b/michigan/01/2021 antigen (Formaldehyde inactivated), Influenza a virus a/victoria/4897/2022 ivr-238 (H1n1) antigen (Formaldehyde inactivated).

Who is the labeler?

Patheon Manufacturing Services LLC, NDC labeler code 63552. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Fluzone High Dose Northern Hemisphere?

1 other product NDC are listed under this name. See all Fluzone High Dose Northern Hemisphere NDCs.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory. See Billing references above.

Related NDCs: other Fluzone High Dose Northern Hemisphere products

Other finished products listed under the same name: strengths, forms and labelers.

Other NDCs under BLA 103914

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.