FDA.reportPublic FDA data

DTap-IPV-Hib-HepB (generic for Vaxelis) 0.5 ML Prefilled Syringe

RxCUI
2468237
RxNorm name
DTap-IPV-Hib-HepB (generic for Vaxelis) 0.5 ML Prefilled Syringe
Display name
DTap-IPV-Hib-HepB (generic for Vaxelis) 0.5 ML Prefilled Syringe
Full name
DTap-IPV-Hib-HepB (generic for Vaxelis) 0.5 ML Prefilled Syringe
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:55

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125563VaxelisDiphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B 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)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
3ed8472a-c6eb-4076-9d66-025ede589e3dDTap-IPV-Hib-HepB (generic for Vaxelis) 0.5 ML Prefilled Syringe [PSN] · 0.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.04 MG/ML / Bordetella pertussis fimbriae 2/3 vaccine, inactivated 0.01 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.006 MG/ML / Bordetella pertussis toxoid vaccine, inactivated 0.04 MG/ML / diphtheria toxoid vaccine, inactivated 30 UNT/ML / Haemophilus influenzae b (Ross strain) capsular polysaccharide meningococcal protein conjugate vaccine 0.006 MG/ML / hepatitis B surface antigen vaccine 0.02 MG/ML / poliovirus vaccine inactivated, type 1 (Mahoney) 58 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 14 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 52 UNT/ML / tetanus toxoid vac [SCD] · DTap-IPV-Hib-HepB 0.5 ML Prefilled Syringe [SY]314These highlights do not include all the information needed to use VAXELIS safely and effectively. See full prescribing information for VAXELIS. VAXELIS ® (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine) injectable suspension, for intramuscular use Initial U.S. Approval: 201820260428
174faf80-eb4f-4f11-b875-d74bd26c2e65DTap-IPV-Hib-HepB (generic for Vaxelis) 0.5 ML Prefilled Syringe [PSN] · 0.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.04 MG/ML / Bordetella pertussis fimbriae 2/3 vaccine, inactivated 0.01 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.006 MG/ML / Bordetella pertussis toxoid vaccine, inactivated 0.04 MG/ML / diphtheria toxoid vaccine, inactivated 30 UNT/ML / Haemophilus influenzae b (Ross strain) capsular polysaccharide meningococcal protein conjugate vaccine 0.006 MG/ML / hepatitis B surface antigen vaccine 0.02 MG/ML / poliovirus vaccine inactivated, type 1 (Mahoney) 58 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 14 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 52 UNT/ML / tetanus toxoid vac [SCD] · DTap-IPV-Hib-HepB 0.5 ML Prefilled Syringe [SY]31These highlights do not include all the information needed to use VAXELIS safely and effectively. See full prescribing information for VAXELIS. VAXELIS ® (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine) Suspension for Intramuscular Injection Initial U.S. Approval: 201820250513