FDA.reportPublic FDA data

Twinrix Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine 1 ML Prefilled Syringe

RxCUI
803371
RxNorm name
Twinrix Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine 1 ML Prefilled Syringe
Display name
Twinrix Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine 1 ML Prefilled Syringe
Full name
Twinrix Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine 1 ML Prefilled Syringe
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:48

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103850TwinrixHepatitis A & Hepatitis B (Recombinant) Vaccine351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

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UNII Substances#

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Reported adverse events (FAERS/openFDA)#

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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
18e8f9fc-4d62-4d30-4ab7-bac03336171eTWINRIX vaccine 1 ML Prefilled Syringe [PSN] · 1 ML hepatitis A vaccine (inactivated) strain HM175 720 UNT/ML / hepatitis B surface antigen vaccine 0.02 MG/ML Prefilled Syringe [Twinrix] [SBD] · Twinrix Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine 1 ML Prefilled Syringe [SY]334These highlights do not include all the information needed to use TWINRIX safely and effectively. See full prescribing information for TWINRIX. TWINRIX [Hepatitis A & Hepatitis B (Recombinant) Vaccine] injectable suspension, for intramuscular use Initial U.S. Approval: 200120260514
dad367dd-7cb8-4344-9920-8710149473d2TWINRIX vaccine 1 ML Prefilled Syringe [PSN] · 1 ML hepatitis A vaccine (inactivated) strain HM175 720 UNT/ML / hepatitis B surface antigen vaccine 0.02 MG/ML Prefilled Syringe [Twinrix] [SBD] · Twinrix Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine 1 ML Prefilled Syringe [SY]319These highlights do not include all the information needed to use TWINRIX safely and effectively. See full prescribing information for TWINRIX. TWINRIX [Hepatitis A & Hepatitis B (Recombinant) Vaccine] injectable suspension, for intramuscular use Initial U.S. Approval: 200120231209