FDA.reportPublic FDA data

Havrix, Hepatitis A Vaccine (Inactivated), (Pediatric Dose) 0.5 ML Prefilled Syringe

RxCUI
798482
RxNorm name
Havrix, Hepatitis A Vaccine (Inactivated), (Pediatric Dose) 0.5 ML Prefilled Syringe
Display name
Havrix, Hepatitis A Vaccine (Inactivated), (Pediatric Dose) 0.5 ML Prefilled Syringe
Full name
Havrix, Hepatitis A Vaccine (Inactivated), (Pediatric Dose) 0.5 ML Prefilled Syringe
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:29

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103475HavrixHepatitis A Vaccine351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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No records found.

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 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
f9499a4d-1288-4bd3-9d59-1d72092c38cdHAVRIX pediatric/adolescent vaccine 720 UNT in 0.5 ML Prefilled Syringe [PSN] · 0.5 ML hepatitis A vaccine (inactivated) strain HM175 1440 UNT/ML Prefilled Syringe [Havrix] [SBD] · Havrix 720 UNT per 0.5 ML Prefilled Syringe, 0.5 ML [SY] · Havrix, Hepatitis A Vaccine (Inactivated), (Pediatric Dose) 0.5 ML Prefilled Syringe [SY]433These highlights do not include all the information needed to use HAVRIX safely and effectively. See full prescribing information for HAVRIX. HAVRIX (Hepatitis A Vaccine) injectable suspension, for intramuscular use Initial U.S. Approval: 199520260514
7df68090-7e98-4b01-9c29-0b941a1c307dHAVRIX pediatric/adolescent vaccine 720 UNT in 0.5 ML Prefilled Syringe [PSN] · 0.5 ML hepatitis A vaccine (inactivated) strain HM175 1440 UNT/ML Prefilled Syringe [Havrix] [SBD] · Havrix 720 UNT per 0.5 ML Prefilled Syringe, 0.5 ML [SY] · Havrix, Hepatitis A Vaccine (Inactivated), (Pediatric Dose) 0.5 ML Prefilled Syringe [SY]413These highlights do not include all the information needed to use HAVRIX safely and effectively. See full prescribing information for HAVRIX. HAVRIX (Hepatitis A Vaccine) injectable suspension, for intramuscular use Initial U.S. Approval: 199520240625