FDA.reportPublic FDA data

Heplisav-B 0.04 MG/ML per 0.5 ML Injection

RxCUI
1994352
RxNorm name
Heplisav-B 0.04 MG/ML per 0.5 ML Injection
Display name
Heplisav-B 0.04 MG/ML per 0.5 ML Injection
Full name
Heplisav-B 0.04 MG/ML per 0.5 ML Injection
Term type
SY
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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No records found.

UNII Substances#

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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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
d61c7f99-438b-4cac-ae10-997ff4c0fd1fHEPLISAV-B 20 MCG in 0.5 ML Injection [PSN] · 0.5 ML hepatitis B surface antigen vaccine 0.04 MG/ML Injection [Heplisav-B] [SBD] · Heplisav-B 0.04 MG/ML per 0.5 ML Injection [SY] · Heplisav-B 20 MCG per 0.5 ML Injection [SY]410These 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