FDA.reportPublic FDA data

0.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML Prefilled Syringe [Recombivax]

RxCUI
830253
RxNorm name
0.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML Prefilled Syringe [Recombivax]
Display name
0.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML Prefilled Syringe [Recombivax]
Full name
0.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML Prefilled Syringe [Recombivax]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:17

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
101066Recombivax, Recombivax HbHepatitis B Vaccine (Recombinant)351(a)Rx2026-08-01

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 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
b5bd99e4-569d-48d5-ba75-16e69f8c409aRECOMBIVAX HB pediatric/adolescent vaccine 0.5 ML Prefilled Syringe [PSN] · 0.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML Prefilled Syringe [Recombivax] [SBD] · 0.5 ML Recombivax HB Pediatric/Adolescent 10 MCG/ML Prefilled Syringe [SY] · 0.5 ML Recombivax HB, hepatitis B vaccine (recombinant) Prefilled Syringe [SY] · Recombivax HB 5 MCG per 0.5 ML Prefilled Syringe [SY]532These highlights do not include all the information needed to use RECOMBIVAX HB safely and effectively. See full prescribing information for RECOMBIVAX HB. RECOMBIVAX HB® Hepatitis B Vaccine (Recombinant) Suspension for intramuscular injection Initial U.S. Approval: 198620241031
4c4c3b6a-0522-51a3-e063-6394a90ac5edRECOMBIVAX HB pediatric/adolescent vaccine 0.5 ML Prefilled Syringe [PSN] · 0.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML Prefilled Syringe [Recombivax] [SBD] · 0.5 ML Recombivax HB Pediatric/Adolescent 10 MCG/ML Prefilled Syringe [SY] · 0.5 ML Recombivax HB, hepatitis B vaccine (recombinant) Prefilled Syringe [SY] · Recombivax HB 5 MCG per 0.5 ML Prefilled Syringe [SY]51RECOMBIVAX HB® Hepatitis B Vaccine (Recombinant) Suspension for intramuscular injection Initial U.S. Approval: 1986 These highlights do not include all the information needed to use RECOMBIVAX HB safely and effectively. See full prescribing information for RECOMBIVAX HB.20260305