FDA.reportPublic FDA data

Vaxelis 0.5 ML Prefilled Syringe

RxCUI
2468239
RxNorm name
Vaxelis 0.5 ML Prefilled Syringe
Display name
Vaxelis 0.5 ML Prefilled Syringe
Full name
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)Rx2026-06-01

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
3ed8472a-c6eb-4076-9d66-025ede589e3dVaxelis 0.5 ML Prefilled SyringePSN14These 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
3ed8472a-c6eb-4076-9d66-025ede589e3d0.5 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 vacSBD14These 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
3ed8472a-c6eb-4076-9d66-025ede589e3dVaxelis (Diphtheria and Tetanus Toxoids and Acelluar Pertussis Absorbed, Inactivated Poliovirus, Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine) 0.5 ML Prefilled SyringeSY14These 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-d74bd26c2e65Vaxelis (Diphtheria and Tetanus Toxoids and Acelluar Pertussis Absorbed, Inactivated Poliovirus, Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine) 0.5 ML Prefilled SyringeSY1These 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
174faf80-eb4f-4f11-b875-d74bd26c2e650.5 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 vacSBD1These 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
174faf80-eb4f-4f11-b875-d74bd26c2e65Vaxelis 0.5 ML Prefilled SyringePSN1These 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