FDA.reportPublic FDA data

ENGERIX-B pediatric/adolescent 10 MCG in 0.5 ML Prefilled Syringe

RxCUI
798430
RxNorm name
ENGERIX-B pediatric/adolescent 10 MCG in 0.5 ML Prefilled Syringe
Display name
ENGERIX-B pediatric/adolescent 10 MCG in 0.5 ML Prefilled Syringe
Full name
ENGERIX-B pediatric/adolescent 10 MCG in 0.5 ML Prefilled Syringe
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:52

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103239Engerix-BHepatitis 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
2ec65f7e-4aa2-4b41-b578-885ea59d6e9dENGERIX-B pediatric/adolescent 10 MCG in 0.5 ML Prefilled Syringe [PSN] · 0.5 ML hepatitis B surface antigen vaccine 0.02 MG/ML Prefilled Syringe [Engerix-B] [SBD] · 0.5 ML Engerix-B Pediatric 20 MCG/ML Prefilled Syringe [SY] · Engerix-B 10 MCG per 0.5 ML Prefilled Syringe [SY] · Engerix-B, Hepatitis B Surface Antigen Vaccine, Adsorbed (Pediatric Dose) 0.5 ML Prefilled Syringe [SY]534These highlights do not include all the information needed to use ENGERIX-B safely and effectively. See full prescribing information for ENGERIX-B. ENGERIX-B [Hepatitis B Vaccine (Recombinant)] injectable suspension, for intramuscular use Initial U.S. Approval: 198920260514
9a4037a2-6c63-457a-8d6f-2fd05d926ea2ENGERIX-B pediatric/adolescent 10 MCG in 0.5 ML Prefilled Syringe [PSN] · 0.5 ML hepatitis B surface antigen vaccine 0.02 MG/ML Prefilled Syringe [Engerix-B] [SBD] · 0.5 ML Engerix-B Pediatric 20 MCG/ML Prefilled Syringe [SY] · Engerix-B 10 MCG per 0.5 ML Prefilled Syringe [SY] · Engerix-B, Hepatitis B Surface Antigen Vaccine, Adsorbed (Pediatric Dose) 0.5 ML Prefilled Syringe [SY]513These highlights do not include all the information needed to use ENGERIX-B safely and effectively. See full prescribing information for ENGERIX-B. ENGERIX-B [Hepatitis B Vaccine (Recombinant)] Suspension for Intramuscular Injection Initial U.S. Approval: 198920200118