FDA.reportPublic FDA data

0.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML Injection

RxCUI
1658154
RxNorm name
0.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML Injection
Display name
0.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML Injection
Full name
0.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML Injection
Term type
SCD
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)Rx2026-08-01

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 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
b5bd99e4-569d-48d5-ba75-16e69f8c409ahepatitis B vaccine (recombinant) pediatric/adolescent (HepB) 5 MCG/0.5 ML Injection [PSN] · 0.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML Injection [SCD] · hepatitis B surface antigen vaccine 5 MCG per 0.5 ML Injection [SY]332These 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
f1ad4bca-839d-41cd-a132-a6984780912ehepatitis B vaccine (recombinant) pediatric/adolescent (HepB) 5 MCG/0.5 ML Injection [PSN] · 0.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML Injection [SCD] · hepatitis B surface antigen vaccine 5 MCG per 0.5 ML Injection [SY]315These 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: 198620210616