FDA.reportPublic FDA data

Capvaxive (Pneumococcal 21-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) 0.5 ML Prefilled Syringe

RxCUI
2686978
RxNorm name
Capvaxive (Pneumococcal 21-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) 0.5 ML Prefilled Syringe
Display name
Capvaxive (Pneumococcal 21-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) 0.5 ML Prefilled Syringe
Full name
Capvaxive (Pneumococcal 21-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) 0.5 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
125814CAPVAXIVEPneumococcal 21-valent Conjugate 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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
1a264c2f-d2f8-4ab5-bc5e-fbed0001ede6CAPVAXIVE vaccine 0.5 ML Prefilled Syringe [PSN] · 0.5 ML Streptococcus pneumoniae serotype 10A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 11A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 12F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 15A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 16F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 17F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus p [SBD] · Capvaxive (Pneumococcal 21-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) 0.5 ML Prefilled Syringe [SY]34These highlights do not include all the information needed to use CAPVAXIVE safely and effectively. See full prescribing information for CAPVAXIVE. CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) injection, for intramuscular use Initial U.S. Approval: 202420250731