FDA.reportPublic FDA data

meningococcal group B vaccine (MenB generic for Bexsero) 0.5 ML Prefilled Syringe

RxCUI
1601402
RxNorm name
meningococcal group B vaccine (MenB generic for Bexsero) 0.5 ML Prefilled Syringe
Display name
meningococcal group B vaccine (MenB generic for Bexsero) 0.5 ML Prefilled Syringe
Full name
meningococcal group B vaccine (MenB generic for Bexsero) 0.5 ML Prefilled Syringe
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:28

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125546BexseroMeningococcal Group B Vaccine351(a)Rx2026-08-01

RxNav Current And Historical NDCs#

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UNII Substances#

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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
f70cf2fc-6e6d-4a74-9f7a-db8fec072fd7meningococcal group B vaccine (MenB generic for Bexsero) 0.5 ML Prefilled Syringe [PSN] · 0.5 ML meningococcal group B vaccine 0.1 MG/ML / Neisseria meningitidis serogroup B recombinant FHBP fusion protein antigen 0.1 MG/ML / Neisseria meningitidis serogroup B recombinant NHBA fusion protein antigen 0.1 MG/ML / Neisseria meningitidis serogroup B strain NZ98/254 outer membrane vesicle 0.05 MG/ML Prefilled Syringe [SCD] · meningococcal group B vaccine 50 MCG / Neisseria meningitidis serogroup B recombinant FHBP fusion protein antigen 50 MCG / Neisseria meningitidis serogroup B recombinant NHBA fusion protein antigen 50 MCG / Neisseria meningitidis serogroup B strain NZ98/254 outer membrane vesicle 25 MCG per 0.5 ML Prefilled Syringe [SY]311These highlights do not include all the information needed to use BEXSERO safely and effectively. See full prescribing information for BEXSERO. BEXSERO (Meningococcal Group B Vaccine) injectable suspension, for intramuscular use Initial U.S. Approval: 201520240819