FLUZONE TRIVALENT NORTHERN HEMISPHERE

Product NDC: 83703-083
11-digit product format: 837030083
Labeler code: 83703
Product ID: 83703-083_49dd66d9-4deb-ad4c-e063-6394a90aa3ba
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: Bamboo US BidCo LLC
Application: BLA103914
Marketing category: BLA
Marketing start: 2024-07-01
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: 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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)	15 ug/.5mL
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)	15 ug/.5mL
INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)	15 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
83703-083-50	FLUZONE TRIVALENT NORTHERN HEMISPHERE	10 in 1 PACKAGE	INJECTION, SUSPENSION	10		1
83703-083-88	FLUZONE TRIVALENT NORTHERN HEMISPHERE	0.5 mL in 1 SYRINGE, GLASS	INJECTION, SUSPENSION	0.5		1

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2719212	Fluzone 2025-2026 vaccine 0.5 ML Prefilled Syringe	PSN	49dd5fdf-532e-aa5c-e063-6394a90a6cfc	1
2709236	influenza virus vaccine 2025 (trivalent - Croatia/Victoria/Michigan) 0.5 mL Prefilled Syringe	PSN	49dd5fdf-532e-aa5c-e063-6394a90a6cfc	1
2719212	0.5 ML influenza A virus A/Croatia/10136RV/2023 (H3N2) antigen 0.03 MG/ML / influenza A virus A/Victoria/4897/2022 (H1N1) antigen 0.03 MG/ML / influenza B virus B/Michigan/01/2021 antigen 0.03 MG/ML Prefilled Syringe [Fluzone 2025-2026]	SBD	49dd5fdf-532e-aa5c-e063-6394a90a6cfc	1
2709236	0.5 ML influenza A virus A/Croatia/10136RV/2023 (H3N2) antigen 0.03 MG/ML / influenza A virus A/Victoria/4897/2022 (H1N1) antigen 0.03 MG/ML / influenza B virus B/Michigan/01/2021 antigen 0.03 MG/ML Prefilled Syringe	SCD	49dd5fdf-532e-aa5c-e063-6394a90a6cfc	1
2719212	Fluzone 2025-2026 vaccine 0.5 ML Prefilled Syringe	SY	49dd5fdf-532e-aa5c-e063-6394a90a6cfc	1
2709236	influenza virus vaccine 2025 (trivalent - Croatia/Victoria/Michigan) 0.5 mL Prefilled Syringe	SY	49dd5fdf-532e-aa5c-e063-6394a90a6cfc	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
83703-083-50	83703008350	10 SYRINGE, GLASS in 1 PACKAGE (83703-083-50) / .5 mL in 1 SYRINGE, GLASS (83703-083-88)		2024-07-01	2026-06-30	No	No	Historical
83703-083-88	83703008388	0.5 mL in 1 SYRINGE, GLASS	0.5 ml					Historical