Fluzone High Dose Northern Hemisphere NDC 49281-126

Product information

Brand name (proprietary)

Fluzone High Dose Northern Hemisphere

Generic name (nonproprietary)

influenza a virus a/switzerland/6849/2025 ivr-278 (a/missouri/11/2025 pdm09-like virus) (h1n1) antigen (formaldehyde inactivated), influenza a virus a/michigan/105/2025 san-049a (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/tokyo/eis13-175/2025 antigen (formaldehyde inactivated)

Active ingredients

Influenza a virus a/switzerland/6849/2025 ivr-278 (H1n1) antigen (Formaldehyde inactivated) — 60 ug/.5mLInfluenza a virus a/michigan/105/2025 san-049a (H3n2) antigen (Formaldehyde inactivated) — 60 ug/.5mLInfluenza b virus b/tokyo/eis13-175/2025 antigen (Formaldehyde inactivated) — 60 ug/.5mL

Dosage form

Injection, Suspension

Route

Intramuscular

Labeler

Sanofi Vaccines US Inc.

Product type

Vaccine

Marketing category

BLA — Biologics License ApplicationApplication BLA 103914

Marketing start

Jul 2, 2026

Marketing end

Jun 30, 2027

Identifiers

Product ID 49281-126_0be30702-7ccd-40b3-8db2-b3cdc0de40efSPL ID 0be30702-7ccd-40b3-8db2-b3cdc0de40ef

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

N449281012665 followed by a unit qualifier and the quantity Copy

Package 49281-0126-65. 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.

Other NDCs under BLA 103914

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