Fluzone HD Tiv Sh 2026 NDC 49281-016

Product information

Brand name (proprietary)

Fluzone HD Tiv Sh 2026

Generic name (nonproprietary)

influenza a virus a/switzerland/6849/2025 ivr-278 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/singapore/gp20238/2024 ivr-277 (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated)

Active ingredients

Influenza a virus a/switzerland/6849/2025 ivr-278 (H1n1) antigen (Formaldehyde inactivated) — 60 ug/.5mLInfluenza a virus a/singapore/gp20238/2024 ivr-277 (H3n2) antigen (Formaldehyde inactivated) — 60 ug/.5mLInfluenza b virus b/michigan/01/2021 antigen (Formaldehyde inactivated) — 60 ug/.5mL

Dosage form

Injection, Suspension

Route

Intramuscular

Labeler

Sanofi Vaccines US Inc.NDC labeler code 49281

Product type

Vaccine

Marketing category

BLA — Biologics License ApplicationApplication BLA 103914

Marketing start

Feb 20, 2026

Marketing end

Dec 31, 2026

Identifiers

Product ID 49281-016_602db593-4e91-45de-ac0f-6a8b0312341aSPL ID 602db593-4e91-45de-ac0f-6a8b0312341a

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

N449281001650 followed by a unit qualifier and the quantity Copy

Package 49281-0016-50. 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 49281-016

What is NDC 49281-016?

49281-016 is the product NDC for Fluzone HD Tiv Sh 2026, Influenza a virus a/switzerland/6849/2025 ivr-278 (H1n1) antigen (Formaldehyde inactivated) 60 ug/.5mL + 2 more ingredients injection, suspension, listed with the FDA by Sanofi Vaccines US Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Fluzone HD Tiv Sh 2026 (INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024 IVR-277 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)).

What is the active ingredient?

Influenza a virus a/switzerland/6849/2025 ivr-278 (H1n1) antigen (Formaldehyde inactivated), Influenza a virus a/singapore/gp20238/2024 ivr-277 (H3n2) antigen (Formaldehyde inactivated), Influenza b virus b/michigan/01/2021 antigen (Formaldehyde inactivated).

Who is the labeler?

Sanofi Vaccines US Inc., NDC labeler code 49281. 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 HD Tiv Sh 2026?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

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

Other NDCs under BLA 103914

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