FDA.reportPublic FDA data

Prevnar 13 vaccine 0.5 ML Prefilled Syringe

RxCUI
901644
RxNorm name
Prevnar 13 vaccine 0.5 ML Prefilled Syringe
Display name
Prevnar 13 vaccine 0.5 ML Prefilled Syringe
Full name
Prevnar 13 vaccine 0.5 ML Prefilled Syringe
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:26

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125324Prevnar 13Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)351(a)Disc2026-09-01

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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
e8c6b638-c22f-4c20-ba40-b9d5e85c9541Prevnar 13 vaccine 0.5 ML Prefilled Syringe [PSN] · 0.5 ML Streptococcus pneumoniae serotype 1 capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 14 capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 18C capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 19A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 19F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 23F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcu [SBD] · Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) 0.5 ML Prefilled Syringe [SY]326These highlights do not include all the information needed to use PREVNAR 13 safely and effectively. See full prescribing information for PREVNAR 13. PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM 197 Protein]) Suspension for intramuscular injection Initial U.S. Approval: 201020240524