FDA.reportPublic FDA data

Engerix-B 20 MCG per 1 ML Injection

RxCUI
1658157
RxNorm name
Engerix-B 20 MCG per 1 ML Injection
Display name
Engerix-B 20 MCG per 1 ML Injection
Full name
Engerix-B 20 MCG per 1 ML Injection
Term type
SY
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#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

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
2ec65f7e-4aa2-4b41-b578-885ea59d6e9dENGERIX-B adult 20 MCG in 1 ML Injection [PSN] · 1 ML hepatitis B surface antigen vaccine 0.02 MG/ML Injection [Engerix-B] [SBD] · Engerix-B 20 MCG per 1 ML Injection [SY]334These 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
4d930f24-4ddb-488d-9e79-3f495972733bENGERIX-B adult 20 MCG in 1 ML Injection [PSN] · 1 ML hepatitis B surface antigen vaccine 0.02 MG/ML Injection [Engerix-B] [SBD] · Engerix-B 20 MCG per 1 ML Injection [SY]31ENGERIX-B ® Hepatitis B Vaccine (Recombinant)20100302