FDA.reportPublic FDA data

hepatitis B vaccine (recombinant) pediatric/adolescent 20 MCG in 0.5 ML Injection

RxCUI
1994347
RxNorm name
hepatitis B vaccine (recombinant) pediatric/adolescent 20 MCG in 0.5 ML Injection
Display name
hepatitis B vaccine (recombinant) pediatric/adolescent 20 MCG in 0.5 ML Injection
Full name
hepatitis B vaccine (recombinant) pediatric/adolescent 20 MCG in 0.5 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:23

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125428Heplisav-BHepatitis B Vaccine (Recombinant), Adjuvanted351(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
d61c7f99-438b-4cac-ae10-997ff4c0fd1fhepatitis B vaccine (recombinant) pediatric/adolescent 20 MCG in 0.5 ML InjectionSY10These highlights do not include all the information needed to use HEPLISAV-B ® safely and effectively. See full prescribing information for HEPLISAV-B. HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] injection, for intramuscular use Initial U.S. Approval: 201720260219
d61c7f99-438b-4cac-ae10-997ff4c0fd1fhepatitis B surface antigen vaccine 20 MCG in 0.5 ML InjectionPSN10These highlights do not include all the information needed to use HEPLISAV-B ® safely and effectively. See full prescribing information for HEPLISAV-B. HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] injection, for intramuscular use Initial U.S. Approval: 201720260219
d61c7f99-438b-4cac-ae10-997ff4c0fd1fhepatitis B surface antigen vaccine 20 MCG per 0.5 ML InjectionSY10These highlights do not include all the information needed to use HEPLISAV-B ® safely and effectively. See full prescribing information for HEPLISAV-B. HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] injection, for intramuscular use Initial U.S. Approval: 201720260219
d61c7f99-438b-4cac-ae10-997ff4c0fd1fhepatitis B surface antigen vaccine 0.04 MG/ML per 0.5 ML InjectionSY10These highlights do not include all the information needed to use HEPLISAV-B ® safely and effectively. See full prescribing information for HEPLISAV-B. HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] injection, for intramuscular use Initial U.S. Approval: 201720260219
d61c7f99-438b-4cac-ae10-997ff4c0fd1f0.5 ML hepatitis B surface antigen vaccine 0.04 MG/ML InjectionSCD10These highlights do not include all the information needed to use HEPLISAV-B ® safely and effectively. See full prescribing information for HEPLISAV-B. HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] injection, for intramuscular use Initial U.S. Approval: 201720260219