FDA.reportPublic FDA data

hepatitis B surface antigen vaccine 20 MCG in 0.5 ML Prefilled Syringe

RxCUI
2050057
RxNorm name
hepatitis B surface antigen vaccine 20 MCG in 0.5 ML Prefilled Syringe
Display name
hepatitis B surface antigen vaccine 20 MCG in 0.5 ML Prefilled Syringe
Full name
hepatitis B surface antigen vaccine 20 MCG in 0.5 ML Prefilled Syringe
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:23

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125428Heplisav-BHepatitis B Vaccine (Recombinant), Adjuvanted351(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 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
d61c7f99-438b-4cac-ae10-997ff4c0fd1fhepatitis B surface antigen vaccine 20 MCG in 0.5 ML Prefilled Syringe [PSN] · 0.5 ML hepatitis B surface antigen vaccine 0.04 MG/ML Prefilled Syringe [SCD] · hepatitis B surface antigen vaccine 0.04 MG/ML per 0.5 ML Prefilled Syringe [SY]310These highlights do not include all the information needed to use HEPLISAV-B ® safely and effectively. See full prescribing information for HEPLISAV-B. HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] injection, for intramuscular use Initial U.S. Approval: 201720260219
618db7b8-a5e4-49c8-9390-38912e6f39fdhepatitis B surface antigen vaccine 20 MCG in 0.5 ML Prefilled Syringe [PSN] · 0.5 ML hepatitis B surface antigen vaccine 0.04 MG/ML Prefilled Syringe [SCD] · hepatitis B surface antigen vaccine 0.04 MG/ML per 0.5 ML Prefilled Syringe [SY]310These highlights do not include all the information needed to use HEPLISAV-B ® safely and effectively. See full prescribing information for HEPLISAV-B. HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] injection, for intramuscular use Initial U.S. Approval: 201720250416
1a8b8271-208d-ecde-e063-6294a90a54c6hepatitis B surface antigen vaccine 20 MCG in 0.5 ML Prefilled Syringe [PSN] · 0.5 ML hepatitis B surface antigen vaccine 0.04 MG/ML Prefilled Syringe [SCD] · hepatitis B surface antigen vaccine 0.04 MG/ML per 0.5 ML Prefilled Syringe [SY]35These highlights do not include all the information needed to use HEPLISAV-B ® safely and effectively. See full prescribing information for HEPLISAV-B. HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] Solution for Intramuscular Injection Initial U.S. Approval: 201720260202