FDA.reportPublic FDA data

Hepatitis B (Recombinant) Vaccine 1 ML Injection

RxCUI
2588237
RxNorm name
Hepatitis B (Recombinant) Vaccine 1 ML Injection
Display name
Hepatitis B (Recombinant) Vaccine 1 ML Injection
Full name
Hepatitis B (Recombinant) Vaccine 1 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:54

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125737PrehevbrioHepatitis B Vaccine (Recombinant)351(a)Disc2026-09-01

RxNav Current And Historical NDCs#

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No records found.

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
36e9a878-d6c2-4808-9915-294f47b1fe3dHepatitis B (Recombinant) Vaccine 1 ML Injection [PSN] · 1 ML hepatitis B surface antigen (isoform L), recombinant 0.01 MG/ML / hepatitis B surface antigen (isoform M), recombinant 0.01 MG/ML / hepatitis B surface antigen (isoform S), recombinant 0.01 MG/ML Injection [SCD]26These highlights do not include all the information needed to use PREHEVBRIO TM safely and effectively. See full prescribing information for PREHEVBRIO. PREHEVBRIO [Hepatitis B Vaccine (Recombinant)] Injectable suspension, for intramuscular use Initial U.S. Approval: 202120240222