FDA.reportPublic FDA data

influenza A (H5N8) virus vaccine (monovalent - Astrakhan/3212/2020) Injectable Suspension

RxCUI
2743203
RxNorm name
influenza A (H5N8) virus vaccine (monovalent - Astrakhan/3212/2020) Injectable Suspension
Display name
influenza A (H5N8) virus vaccine (monovalent - Astrakhan/3212/2020) Injectable Suspension
Full name
influenza A (H5N8) virus vaccine (monovalent - Astrakhan/3212/2020) Injectable Suspension
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:26

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125419ArepanrixInfluenza A [H5] Monovalent Vaccine, Adjuvanted351(a)Disc2026-06-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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No records found.

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
ecf36ac9-9eb7-4008-8657-9bb6fb1bb28cinfluenza A (H5N8) virus vaccine (monovalent - Astrakhan/3212/2020) Injectable SuspensionPSN1These highlights do not include all the information needed to use AREPANRIX safely and effectively. See full prescribing information for AREPANRIX. AREPANRIX (Influenza A [H5] Monovalent Vaccine, Adjuvanted) injectable emulsion, for intramuscular use Initial U.S. Approval: 201320260428
ecf36ac9-9eb7-4008-8657-9bb6fb1bb28cinfluenza A (H5N8) virus vaccine (monovalent - Astrakhan/3212/2020) Injectable SuspensionSY1These highlights do not include all the information needed to use AREPANRIX safely and effectively. See full prescribing information for AREPANRIX. AREPANRIX (Influenza A [H5] Monovalent Vaccine, Adjuvanted) injectable emulsion, for intramuscular use Initial U.S. Approval: 201320260428
ecf36ac9-9eb7-4008-8657-9bb6fb1bb28cinfluenza A virus A/Astrakhan/3212/2020 (H5N8) antigen 0.0075 MG/ML Injectable SuspensionSCD1These highlights do not include all the information needed to use AREPANRIX safely and effectively. See full prescribing information for AREPANRIX. AREPANRIX (Influenza A [H5] Monovalent Vaccine, Adjuvanted) injectable emulsion, for intramuscular use Initial U.S. Approval: 201320260428