FDA.reportPublic FDA data

FLUZONE HIGH DOSE NORTHERN HEMISPHERE

Product NDC
49281-126
11-digit product format
492810126
Labeler code
49281
Product ID
49281-126_0be30702-7ccd-40b3-8db2-b3cdc0de40ef
Type
VACCINE
Nonproprietary name
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)
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Application
BLA103914
Marketing category
BLA
Marketing start
2026-07-02
Marketing end
2027-06-30
Substance
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)
Active strength
60 ug/.5mL
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FLUZONE HIGH DOSE NORTHERN HEMISPHERE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)60 ug/.5mL
INFLUENZA A VIRUS A/MICHIGAN/105/2025 SAN-049A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)60 ug/.5mL
INFLUENZA B VIRUS B/TOKYO/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED)60 ug/.5mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103914Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone QuadrivalentInfluenza Virus Vaccine351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2718469Fluzone 2025-2026 high-dose vaccine 0.5 ML Prefilled SyringePSNde0e2089-f781-4d47-99f5-c2a1b7b0f1eb6
2709013influenza virus vaccine 2025 high dose (trivalent - Croatia/Victoria/Michigan) 0.5 mL Prefilled SyringePSNde0e2089-f781-4d47-99f5-c2a1b7b0f1eb6
27184690.5 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]SBDde0e2089-f781-4d47-99f5-c2a1b7b0f1eb6
27090130.5 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 SyringeSCDde0e2089-f781-4d47-99f5-c2a1b7b0f1eb6
2718469Fluzone 2025-2026 high-dose vaccine 0.5 ML Prefilled SyringeSYde0e2089-f781-4d47-99f5-c2a1b7b0f1eb6
2709013influenza virus vaccine 2025 high dose (trivalent - Croatia/Victoria/Michigan) 0.5 mL Prefilled SyringeSYde0e2089-f781-4d47-99f5-c2a1b7b0f1eb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleStatus
49281-126-65492810126655 SYRINGE, GLASS in 1 PACKAGE (49281-126-65) / .5 mL in 1 SYRINGE, GLASS (49281-126-88)2026-07-022027-06-300Historical