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FLUZONE TRIVALENT NORTHERN HEMISPHERE

NDC 49281-645 · Sanofi Vaccines US Inc.

Generic nameINFLUENZA A VIRUS A/Switzerland/6849/2025 IVR-278 (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)
Dosage formINJECTION, SUSPENSION
RouteINTRAMUSCULAR
Active ingredient(s)INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/MICHIGAN/105/2025 SAN-049A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/TOKYO/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED)
Strength15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL
Marketing categoryBLA

Packages

49281-645-15 — 1 VIAL, MULTI-DOSE in 1 PACKAGE (49281-645-15) / 5 mL in 1 VIAL, MULTI-DOSE (49281-645-78)

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

49281-016 — INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024…, 49281-126 — INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (A/MISSOURI/11/2025 PDM09-LIKE VIRUS) (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED),…, 49281-315 — INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024…, 49281-426 — INFLUENZA A VIRUS A/Switzerland/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Michigan/105/2025 SAN-049A…, 49281-626 — INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024…, 70461-026 — INFLUENZA A VIRUS A/Missouri/11/2025 IVR-279 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Michigan/105/2025 IVR-285…

Read from: FDA National Drug Code Directory, product.txt and package.txt (accessdata.fda.gov/cder/ndctext.zip) — Snapshot retrieved 2026-08-24, loaded 2026-08-24; CMS Medicare Part B Drug Average Sales Price (ASP) Pricing Files (cms.gov/medicare/payment/part-b-drugs/asp-pricing-files) -- the NDC-HCPCS crosswalk and Part B payment limit files — 2026 Q3 (July 2026 release). All data sources · How to read the labels