FLUZONE HD TIV SH 2026

Product NDC: 49281-016
11-digit product format: 492810016
Labeler code: 49281
Product ID: 49281-016_602db593-4e91-45de-ac0f-6a8b0312341a
Type: VACCINE
Nonproprietary name: INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024 IVR-277 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)
Dosage form: INJECTION, SUSPENSION
Route: INTRAMUSCULAR
Labeler: Sanofi Vaccines US Inc.
Application: BLA103914
Marketing category: BLA
Marketing start: 2026-02-20
Marketing end: 2026-12-31
Substance: INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024 IVR-277 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (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/SINGAPORE/GP20238/2024 IVR-277 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)	60 ug/.5mL
INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (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
49281-016-50	FLUZONE HD TIV SH 2026	10 in 1 PACKAGE	INJECTION, SUSPENSION	10		14
49281-016-88	FLUZONE HD TIV SH 2026	0.5 mL in 1 SYRINGE, GLASS	INJECTION, SUSPENSION	0.5		14

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2738157	Fluzone 2026 Southern Hemisphere high dose vaccine 0.5 mL Prefilled Syringe	PSN	96ca1b4c-67bf-3db6-24c5-c4841b073c66	14
2738154	influenza virus vaccine 2026 high dose (trivalent - Singapore/Switzerland/Michigan) 0.5 mL Prefilled Syringe	PSN	96ca1b4c-67bf-3db6-24c5-c4841b073c66	14
2738157	0.5 ML influenza A virus A/Singapore/GP20238/2024 (H3N2) antigen 0.12 MG/ML / influenza A virus A/Switzerland/6849/2025 (H1N1) antigen 0.12 MG/ML / influenza B virus B/Michigan/01/2021 antigen 0.12 MG/ML Prefilled Syringe [Fluzone 2026 Southern Hemisphere]	SBD	96ca1b4c-67bf-3db6-24c5-c4841b073c66	14
2738154	0.5 ML influenza A virus A/Singapore/GP20238/2024 (H3N2) antigen 0.12 MG/ML / influenza A virus A/Switzerland/6849/2025 (H1N1) antigen 0.12 MG/ML / influenza B virus B/Michigan/01/2021 antigen 0.12 MG/ML Prefilled Syringe	SCD	96ca1b4c-67bf-3db6-24c5-c4841b073c66	14
2738157	Fluzone 2026 Southern Hemisphere high dose vaccine 0.5 mL Prefilled Syringe	SY	96ca1b4c-67bf-3db6-24c5-c4841b073c66	14
2738154	influenza virus vaccine 2026 high dose (trivalent - Singapore/Switzerland/Michigan) 0.5 mL Prefilled Syringe	SY	96ca1b4c-67bf-3db6-24c5-c4841b073c66	14

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49281-016-50	49281001650	10 SYRINGE, GLASS in 1 PACKAGE (49281-016-50) / .5 mL in 1 SYRINGE, GLASS (49281-016-88)		2026-02-20	2026-12-31	No	No	Historical
49281-016-88	49281001688	0.5 mL in 1 SYRINGE, GLASS	0.5 ml					Historical