FDA.reportPublic FDA data

0.5 ML 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 Prefilled Syringe

RxCUI
2718378
RxNorm name
0.5 ML 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 Prefilled Syringe
Display name
0.5 ML 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 Prefilled Syringe
Full name
0.5 ML 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 Prefilled Syringe
Term type
SCD
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)Disc2026-06-01

RxNav Current And Historical NDCs#

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UNII Substances#

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DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
3513dfb0-4d62-4ad1-bb15-75c7555896ff0.5 ML 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 Prefilled SyringeSCD12These 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
3513dfb0-4d62-4ad1-bb15-75c7555896ffinfluenza virus vaccine 2025-2026 (trivalent - Georgia/Victoria/Singapore) 0.5 ML Prefilled SyringePSN12These 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
3513dfb0-4d62-4ad1-bb15-75c7555896ffinfluenza virus vaccine 2025-2026 (trivalent - Georgia/Victoria/Singapore) 0.5 ML Prefilled SyringeSY12These 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
49ddaee7-fd56-ecb9-e063-6294a90a6ed6influenza virus vaccine 2025-2026 (trivalent - Georgia/Victoria/Singapore) 0.5 ML Prefilled SyringePSN1FLUCELVAX (Influenza Vaccine) Injectable Suspension, for Intramuscular Use 2025-2026 Formula Initial U.S. Approval: 201220260202
49ddaee7-fd56-ecb9-e063-6294a90a6ed60.5 ML 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 Prefilled SyringeSCD1FLUCELVAX (Influenza Vaccine) Injectable Suspension, for Intramuscular Use 2025-2026 Formula Initial U.S. Approval: 201220260202
49ddaee7-fd56-ecb9-e063-6294a90a6ed6influenza virus vaccine 2025-2026 (trivalent - Georgia/Victoria/Singapore) 0.5 ML Prefilled SyringeSY1FLUCELVAX (Influenza Vaccine) Injectable Suspension, for Intramuscular Use 2025-2026 Formula Initial U.S. Approval: 201220260202