Fluzone High-Dose Quadrivalent Northern Hemisphere

Product NDC
49281-226
11-digit product format
492810226
Labeler code
49281
Product ID
49281-226_b72ec1ef-74b9-42b3-b7cf-302a2cb07409
Type
VACCINE
Nonproprietary name
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Croatia/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 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); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)
Active strength
60; 60; 60; 60 ug/.7mL; ug/.7mL; ug/.7mL; ug/.7mL
NDC exclude flag
No
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49281-226-65Fluzone High-Dose Quadrivalent Northern Hemisphere10 in 1 PACKAGEINJECTION, SUSPENSION1020
49281-226-88Fluzone High-Dose Quadrivalent Northern Hemisphere0.7 mL in 1 SYRINGE, GLASSINJECTION, SUSPENSION0.720

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2719414Fluzone Quadrivalent 2025-2026 high dose vaccine 0.7 ML Prefilled SyringePSN03f2c9fc-534b-49ec-9113-81938b1eadb920
2709025influenza virus vaccine 2025 (quadrivalent - Croatia/Victoria/Michigan/Phuket) 0.7 mL Prefilled SyringePSN03f2c9fc-534b-49ec-9113-81938b1eadb920
27194140.7 ML influenza A virus A/Croatia/10136RV/2023 (H3N2) antigen 0.0857 MG/ML / influenza A virus A/Victoria/4897/2022 (H1N1) antigen 0.0857 MG/ML / influenza B virus B/Michigan/01/2021 antigen 0.0857 MG/ML / influenza B virus B/Phuket/3073/2013 antigen 0.0857 MG/ML Prefilled Syringe [Fluzone Quadrivalent 2025-2026]SBD03f2c9fc-534b-49ec-9113-81938b1eadb920
27090250.7 ML influenza A virus A/Croatia/10136RV/2023 (H3N2) antigen 0.0857 MG/ML / influenza A virus A/Victoria/4897/2022 (H1N1) antigen 0.0857 MG/ML / influenza B virus B/Michigan/01/2021 antigen 0.0857 MG/ML / influenza B virus B/Phuket/3073/2013 antigen 0.0857 MG/ML Prefilled SyringeSCD03f2c9fc-534b-49ec-9113-81938b1eadb920
2719414Fluzone Quadrivalent 2025-2026 high dose vaccine 0.7 ML Prefilled SyringeSY03f2c9fc-534b-49ec-9113-81938b1eadb920
2709025influenza virus vaccine 2025 (quadrivalent - Croatia/Victoria/Michigan/Phuket) 0.7 mL Prefilled SyringeSY03f2c9fc-534b-49ec-9113-81938b1eadb920

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49281-226-654928102266510 SYRINGE, GLASS in 1 PACKAGE (49281-226-65) / .7 mL in 1 SYRINGE, GLASS (49281-226-88) 2025-07-012026-06-30NoNoHistorical
49281-226-88492810226880.7 mL in 1 SYRINGE, GLASS0.7 mlHistorical