FDA.reportPublic FDA data

FLUZONE HIGH DOSE NORTHERN HEMISPHERE

Product NDC
49281-125
Requested package NDC
49281-125-65
11-digit product format
492810125
Labeler code
49281
Product ID
49281-125_17f23433-be13-4279-8cac-775ae71d4329
Type
VACCINE
Nonproprietary name
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)
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Sanofi Pasteur Inc.
Application
BLA103914
Marketing category
BLA
Marketing start
2025-07-01
Marketing end
2026-06-30
Substance
INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)
Active strength
60; 60; 60 ug/.5mL; ug/.5mL; ug/.5mL
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49281-12549281-125-65DDiscontinued by firm2026-08-17

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49281-125-65FLUZONE HIGH DOSE NORTHERN HEMISPHERE5 in 1 PACKAGEINJECTION, SUSPENSION56
49281-125-88FLUZONE HIGH DOSE NORTHERN HEMISPHERE0.5 mL in 1 SYRINGE, GLASSINJECTION, SUSPENSION0.56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49281-125-65ML - Milliliter49281-125c5a945cc-fe53-44e0-8c67-6f4ca134915e12025-08-11
49281-125-88ML - Milliliter49281-1257a72a0ab-933d-462d-91db-7b490bac746c12025-08-11

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)Rx2026-07-01

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 endSampleExclude flagStatus
49281-125-65492810125655 SYRINGE, GLASS in 1 PACKAGE (49281-125-65) / .5 mL in 1 SYRINGE, GLASS (49281-125-88) 2025-07-012026-06-30NoNoHistorical