FDA.reportPublic FDA data

HIBERIX vaccine 0.5 ML Injection

RxCUI
1300810
RxNorm name
HIBERIX vaccine 0.5 ML Injection
Display name
HIBERIX vaccine 0.5 ML Injection
Full name
HIBERIX vaccine 0.5 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:03

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125347HiberixHaemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

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No records found.

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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
745ff8df-1618-4b76-9aa1-6f42752c0ddaHIBERIX vaccine 0.5 ML Injection [PSN] · 0.5 ML Haemophilus influenzae type b strain 20752, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine 0.07 MG/ML Injection [Hiberix] [SBD] · 0.5 ML Hiberix 0.07 MG/ML Injection [SY] · Hiberix (Haemophilus influenzae type b strain 20,752, capsular polysaccharide (10 MCG) inactivated tetanus toxoid (25 MCG) conjugate vaccine) per 0.5 ML Injection [SY] · Hiberix (Haemophilus influenzae type b strain 20,752, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine) 35 MCG per 0.5 ML Injection [SY]522These highlights do not include all the information needed to use HIBERIX safely and effectively. See full prescribing information for HIBERIX. HIBERIX [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] for injection, for intramuscular use Initial U.S. Approval: 200920250121