FDA.reportPublic FDA data

1 ML hepatitis A vaccine (inactivated) strain HM175 1440 UNT/ML Injection [Havrix]

RxCUI
1658060
RxNorm name
1 ML hepatitis A vaccine (inactivated) strain HM175 1440 UNT/ML Injection [Havrix]
Display name
1 ML hepatitis A vaccine (inactivated) strain HM175 1440 UNT/ML Injection [Havrix]
Full name
1 ML hepatitis A vaccine (inactivated) strain HM175 1440 UNT/ML Injection [Havrix]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:48

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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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
135ff1b4-c21f-4df1-97be-9475680e9e44HAVRIX adult vaccine 1440 UNT in 1 ML Injection [PSN] · 1 ML hepatitis A vaccine (inactivated) strain HM175 1440 UNT/ML Injection [Havrix] [SBD] · 1 ML Havrix 1440 UNT/ML Injection [SY] · Havrix 1440 UNT per 1 ML Injection [SY]41These highlights do not include all the information needed to use HAVRIX safely and effectively. See full prescribing information for HAVRIX. HAVRIX (Hepatitis A Vaccine) Suspension for Intramuscular Injection Initial U.S. Approval: 199520131107