FDA.reportPublic FDA data

hepatitis B surface antigen vaccine 0.01 MG per 1 ML Prefilled Syringe

RxCUI
830243
RxNorm name
hepatitis B surface antigen vaccine 0.01 MG per 1 ML Prefilled Syringe
Display name
hepatitis B surface antigen vaccine 0.01 MG per 1 ML Prefilled Syringe
Full name
hepatitis B surface antigen vaccine 0.01 MG per 1 ML Prefilled Syringe
Term type
SY
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#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
b5bd99e4-569d-48d5-ba75-16e69f8c409a1 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
b5bd99e4-569d-48d5-ba75-16e69f8c409ahepatitis B vaccine (recombinant) adult (HepB) 10 MCG in 1 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 10 MCG per 1 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 0.01 MG per 1 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
4c4c3b6a-0522-51a3-e063-6394a90ac5ed1 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) adult (HepB) 10 MCG in 1 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 10 MCG per 1 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 0.01 MG per 1 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