FDA.reportPublic FDA data

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 / influenza B virus B/Phuket/3073/2013 antigen 0.03 MG/ML Injectable Suspension

RxCUI
2709125
RxNorm name
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 / influenza B virus B/Phuket/3073/2013 antigen 0.03 MG/ML Injectable Suspension
Display name
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 / influenza B virus B/Phuket/3073/2013 antigen 0.03 MG/ML Injectable Suspension
Full name
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 / influenza B virus B/Phuket/3073/2013 antigen 0.03 MG/ML Injectable Suspension
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:06

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103914Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone QuadrivalentInfluenza Virus Vaccine351(a)Rx2026-06-01

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
8213c229-a67a-4d3f-bd8f-b8729ae28472influenza 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 / influenza B virus B/Phuket/3073/2013 antigen 0.03 MG/ML Injectable SuspensionSCD25These highlights do not include all the information needed to use Fluzone ® Quadrivalent safely and effectively. See full prescribing information for Fluzone Quadrivalent. Fluzone Quadrivalent (Influenza Vaccine) injectable suspension, for intramuscular use 2025-2026 Formula Initial U.S. Approval: 201320250711
8213c229-a67a-4d3f-bd8f-b8729ae28472influenza virus vaccine 2025 (quadrivalent - Croatia/Victoria/Michigan/Phuket) Injectable SuspensionPSN25These highlights do not include all the information needed to use Fluzone ® Quadrivalent safely and effectively. See full prescribing information for Fluzone Quadrivalent. Fluzone Quadrivalent (Influenza Vaccine) injectable suspension, for intramuscular use 2025-2026 Formula Initial U.S. Approval: 201320250711
8213c229-a67a-4d3f-bd8f-b8729ae28472influenza virus vaccine 2025 (quadrivalent - Croatia/Victoria/Michigan/Phuket) Injectable SuspensionSY25These highlights do not include all the information needed to use Fluzone ® Quadrivalent safely and effectively. See full prescribing information for Fluzone Quadrivalent. Fluzone Quadrivalent (Influenza Vaccine) injectable suspension, for intramuscular use 2025-2026 Formula Initial U.S. Approval: 201320250711