FLUZONE HIGH DOSE NORTHERN HEMISPHERE

Product NDC: 49281-125
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

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)	60 ug/.5mL
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)	60 ug/.5mL
INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)	60 ug/.5mL

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49281-125-65	FLUZONE HIGH DOSE NORTHERN HEMISPHERE	5 in 1 PACKAGE	INJECTION, SUSPENSION	5		6
49281-125-88	FLUZONE HIGH DOSE NORTHERN HEMISPHERE	0.5 mL in 1 SYRINGE, GLASS	INJECTION, SUSPENSION	0.5		6

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49281-125-65	ML - Milliliter	49281-125	c5a945cc-fe53-44e0-8c67-6f4ca134915e	1	2025-08-11
49281-125-88	ML - Milliliter	49281-125	7a72a0ab-933d-462d-91db-7b490bac746c	1	2025-08-11

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2718469	Fluzone 2025-2026 high-dose vaccine 0.5 ML Prefilled Syringe	PSN	de0e2089-f781-4d47-99f5-c2a1b7b0f1eb	6
2709013	influenza virus vaccine 2025 high dose (trivalent - Croatia/Victoria/Michigan) 0.5 mL Prefilled Syringe	PSN	de0e2089-f781-4d47-99f5-c2a1b7b0f1eb	6
2718469	0.5 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]	SBD	de0e2089-f781-4d47-99f5-c2a1b7b0f1eb	6
2709013	0.5 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	SCD	de0e2089-f781-4d47-99f5-c2a1b7b0f1eb	6
2718469	Fluzone 2025-2026 high-dose vaccine 0.5 ML Prefilled Syringe	SY	de0e2089-f781-4d47-99f5-c2a1b7b0f1eb	6
2709013	influenza virus vaccine 2025 high dose (trivalent - Croatia/Victoria/Michigan) 0.5 mL Prefilled Syringe	SY	de0e2089-f781-4d47-99f5-c2a1b7b0f1eb	6

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49281-125-65	49281012565	5 SYRINGE, GLASS in 1 PACKAGE (49281-125-65) / .5 mL in 1 SYRINGE, GLASS (49281-125-88)		2025-07-01	2026-06-30	No	No	Historical
49281-125-88	49281012588	0.5 mL in 1 SYRINGE, GLASS	0.5 ml					Historical