FDA.reportPublic FDA data

Heplisav-B 0.04 MG/ML per 0.5 ML Prefilled Syringe

RxCUI
2050059
RxNorm name
Heplisav-B 0.04 MG/ML per 0.5 ML Prefilled Syringe
Display name
Heplisav-B 0.04 MG/ML per 0.5 ML Prefilled Syringe
Full name
Heplisav-B 0.04 MG/ML per 0.5 ML Prefilled Syringe
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-ae10-997ff4c0fd1fHeplisav-B 0.04 MG/ML per 0.5 ML Prefilled SyringeSY10These 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 Prefilled Syringe [Heplisav-B]SBD10These 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-ae10-997ff4c0fd1fHEPLISAV-B 20 MCG in 0.5 ML Prefilled SyringePSN10These 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-ae10-997ff4c0fd1fHEPLISAV-B 20 MCG per 0.5 ML Prefilled SyringeSY10These 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 Heplisav-B 0.04 MG/ML Prefilled SyringeSY10These 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
618db7b8-a5e4-49c8-9390-38912e6f39fd0.5 ML Heplisav-B 0.04 MG/ML Prefilled SyringeSY10These 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: 201720250416
618db7b8-a5e4-49c8-9390-38912e6f39fdHEPLISAV-B 20 MCG per 0.5 ML Prefilled SyringeSY10These 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: 201720250416
618db7b8-a5e4-49c8-9390-38912e6f39fd0.5 ML hepatitis B surface antigen vaccine 0.04 MG/ML Prefilled Syringe [Heplisav-B]SBD10These 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: 201720250416
618db7b8-a5e4-49c8-9390-38912e6f39fdHeplisav-B 0.04 MG/ML per 0.5 ML Prefilled SyringeSY10These 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: 201720250416
618db7b8-a5e4-49c8-9390-38912e6f39fdHEPLISAV-B 20 MCG in 0.5 ML Prefilled SyringePSN10These 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: 201720250416
1a8b8271-208d-ecde-e063-6294a90a54c6Heplisav-B 0.04 MG/ML per 0.5 ML Prefilled SyringeSY5These 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] Solution for Intramuscular Injection Initial U.S. Approval: 201720260202
1a8b8271-208d-ecde-e063-6294a90a54c6HEPLISAV-B 20 MCG per 0.5 ML Prefilled SyringeSY5These 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] Solution for Intramuscular Injection Initial U.S. Approval: 201720260202
1a8b8271-208d-ecde-e063-6294a90a54c60.5 ML hepatitis B surface antigen vaccine 0.04 MG/ML Prefilled Syringe [Heplisav-B]SBD5These 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] Solution for Intramuscular Injection Initial U.S. Approval: 201720260202
1a8b8271-208d-ecde-e063-6294a90a54c6HEPLISAV-B 20 MCG in 0.5 ML Prefilled SyringePSN5These 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] Solution for Intramuscular Injection Initial U.S. Approval: 201720260202
1a8b8271-208d-ecde-e063-6294a90a54c60.5 ML Heplisav-B 0.04 MG/ML Prefilled SyringeSY5These 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] Solution for Intramuscular Injection Initial U.S. Approval: 201720260202