FDA.reportPublic FDA data

PEDIARIX vaccine 0.5 ML Prefilled Syringe

RxCUI
829989
RxNorm name
PEDIARIX vaccine 0.5 ML Prefilled Syringe
Display name
PEDIARIX vaccine 0.5 ML Prefilled Syringe
Full name
PEDIARIX vaccine 0.5 ML Prefilled Syringe
Term type
PSN
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
103907PediarixDiphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine351(a)Rx2026-08-01

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
b63c4c7d-3dbf-419d-84cc-2c1957b92be7PEDIARIX vaccine 0.5 ML Prefilled Syringe [PSN] · 0.5 ML acellular pertussis vaccine, inactivated 0.116 MG/ML / diphtheria toxoid vaccine, inactivated 50 UNT/ML / hepatitis B surface antigen vaccine 0.02 MG/ML / poliovirus vaccine inactivated, type 1 (Mahoney) 80 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 16 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 64 UNT/ML / tetanus toxoid vaccine, inactivated 20 UNT/ML Prefilled Syringe [PEDIARIX] [SBD] · PEDIARIX DTaP-HepB-IPV (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine) 0.5 ML Prefilled Syringe [SY]330These highlights do not include all the information needed to use PEDIARIX safely and effectively. See full prescribing information for PEDIARIX. PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] injectable suspension, for intramuscular use Initial U.S. Approval: 200220260514
dd047022-e51c-4aa1-bd68-bc23161c3ce3PEDIARIX vaccine 0.5 ML Prefilled Syringe [PSN] · 0.5 ML acellular pertussis vaccine, inactivated 0.116 MG/ML / diphtheria toxoid vaccine, inactivated 50 UNT/ML / hepatitis B surface antigen vaccine 0.02 MG/ML / poliovirus vaccine inactivated, type 1 (Mahoney) 80 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 16 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 64 UNT/ML / tetanus toxoid vaccine, inactivated 20 UNT/ML Prefilled Syringe [PEDIARIX] [SBD] · PEDIARIX DTaP-HepB-IPV (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine) 0.5 ML Prefilled Syringe [SY]32These highlights do not include all the information needed to use PEDIARIX safely and effectively. See full prescribing information for PEDIARIX. PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine], Suspension for Intramuscular Injection Initial U.S. Approval: 200220250813