FDA.reportPublic FDA data

influenza A virus A/Georgia/12/2022 (H1N1) antigen 0.03 MG/ML / influenza A virus A/Victoria/800/2024 (H3N2) antigen 0.03 MG/ML / influenza B virus B/Singapore/WUH4618/2021 antigen 0.03 MG/ML Injectable Suspension [Flucelvax 2025-2026]

RxCUI
2718374
RxNorm name
influenza A virus A/Georgia/12/2022 (H1N1) antigen 0.03 MG/ML / influenza A virus A/Victoria/800/2024 (H3N2) antigen 0.03 MG/ML / influenza B virus B/Singapore/WUH4618/2021 antigen 0.03 MG/ML Injectable Suspension [Flucelvax 2025-2026]
Display name
influenza A virus A/Georgia/12/2022 (H1N1) antigen 0.03 MG/ML / influenza A virus A/Victoria/800/2024 (H3N2) antigen 0.03 MG/ML / influenza B virus B/Singapore/WUH4618/2021 antigen 0.03 MG/ML Injectable Suspension [Flucelvax 2025-2026]
Full name
influenza A virus A/Georgia/12/2022 (H1N1) antigen 0.03 MG/ML / influenza A virus A/Victoria/800/2024 (H3N2) antigen 0.03 MG/ML / influenza B virus B/Singapore/WUH4618/2021 antigen 0.03 MG/ML Injectable Suspension [Flucelvax 2025-2026]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:53

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125408Flucelvax, Flucelvax QuadrivalentInfluenza Vaccine351(a)Disc2026-08-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
3513dfb0-4d62-4ad1-bb15-75c7555896ffFLUCELVAX 2025-2026 vaccine Injectable Suspension [PSN] · influenza A virus A/Georgia/12/2022 (H1N1) antigen 0.03 MG/ML / influenza A virus A/Victoria/800/2024 (H3N2) antigen 0.03 MG/ML / influenza B virus B/Singapore/WUH4618/2021 antigen 0.03 MG/ML Injectable Suspension [Flucelvax 2025-2026] [SBD] · Flucelvax 2025-2026 vaccine Injectable Suspension [SY]312These highlights do not include all the information needed to use FLUCELVAX ® safely and effectively. See full prescribing information for FLUCELVAX. FLUCELVAX (Influenza Vaccine) Injectable Suspension, for Intramuscular Use 2025-2026 Formula Initial U.S. Approval: 201220260305