FDA.reportPublic FDA data

hepatitis B vaccine (recombinant) pediatric/adolescent (HepB) 5 MCG/0.5 ML Prefilled Syringe

RxCUI
830252
RxNorm name
hepatitis B vaccine (recombinant) pediatric/adolescent (HepB) 5 MCG/0.5 ML Prefilled Syringe
Display name
hepatitis B vaccine (recombinant) pediatric/adolescent (HepB) 5 MCG/0.5 ML Prefilled Syringe
Full name
hepatitis B vaccine (recombinant) pediatric/adolescent (HepB) 5 MCG/0.5 ML Prefilled Syringe
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:17

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
101066Recombivax, Recombivax HbHepatitis B Vaccine (Recombinant)351(a)Rx2026-06-01

RxNav Current And Historical NDCs#

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UNII Substances#

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DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
b5bd99e4-569d-48d5-ba75-16e69f8c409ahepatitis B vaccine (recombinant) pediatric/adolescent (HepB) 5 MCG/0.5 ML Prefilled SyringePSN32These highlights do not include all the information needed to use RECOMBIVAX HB safely and effectively. See full prescribing information for RECOMBIVAX HB. RECOMBIVAX HB® Hepatitis B Vaccine (Recombinant) Suspension for intramuscular injection Initial U.S. Approval: 198620241031
b5bd99e4-569d-48d5-ba75-16e69f8c409ahepatitis B surface antigen vaccine 5 MCG per 0.5 ML Prefilled SyringeSY32These highlights do not include all the information needed to use RECOMBIVAX HB safely and effectively. See full prescribing information for RECOMBIVAX HB. RECOMBIVAX HB® Hepatitis B Vaccine (Recombinant) Suspension for intramuscular injection Initial U.S. Approval: 198620241031
b5bd99e4-569d-48d5-ba75-16e69f8c409ahepatitis B surface antigen vaccine 0.005 MG per 0.5 ML Prefilled SyringeSY32These highlights do not include all the information needed to use RECOMBIVAX HB safely and effectively. See full prescribing information for RECOMBIVAX HB. RECOMBIVAX HB® Hepatitis B Vaccine (Recombinant) Suspension for intramuscular injection Initial U.S. Approval: 198620241031
b5bd99e4-569d-48d5-ba75-16e69f8c409a0.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML Prefilled SyringeSCD32These highlights do not include all the information needed to use RECOMBIVAX HB safely and effectively. See full prescribing information for RECOMBIVAX HB. RECOMBIVAX HB® Hepatitis B Vaccine (Recombinant) Suspension for intramuscular injection Initial U.S. Approval: 198620241031
4c4c3b6a-0522-51a3-e063-6394a90ac5ed0.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML Prefilled SyringeSCD1RECOMBIVAX HB® Hepatitis B Vaccine (Recombinant) Suspension for intramuscular injection Initial U.S. Approval: 1986 These highlights do not include all the information needed to use RECOMBIVAX HB safely and effectively. See full prescribing information for RECOMBIVAX HB.20260305
4c4c3b6a-0522-51a3-e063-6394a90ac5edhepatitis B vaccine (recombinant) pediatric/adolescent (HepB) 5 MCG/0.5 ML Prefilled SyringePSN1RECOMBIVAX HB® Hepatitis B Vaccine (Recombinant) Suspension for intramuscular injection Initial U.S. Approval: 1986 These highlights do not include all the information needed to use RECOMBIVAX HB safely and effectively. See full prescribing information for RECOMBIVAX HB.20260305
4c4c3b6a-0522-51a3-e063-6394a90ac5edhepatitis B surface antigen vaccine 0.005 MG per 0.5 ML Prefilled SyringeSY1RECOMBIVAX HB® Hepatitis B Vaccine (Recombinant) Suspension for intramuscular injection Initial U.S. Approval: 1986 These highlights do not include all the information needed to use RECOMBIVAX HB safely and effectively. See full prescribing information for RECOMBIVAX HB.20260305
4c4c3b6a-0522-51a3-e063-6394a90ac5edhepatitis B surface antigen vaccine 5 MCG per 0.5 ML Prefilled SyringeSY1RECOMBIVAX HB® Hepatitis B Vaccine (Recombinant) Suspension for intramuscular injection Initial U.S. Approval: 1986 These highlights do not include all the information needed to use RECOMBIVAX HB safely and effectively. See full prescribing information for RECOMBIVAX HB.20260305