FDA.reportPublic FDA data

PENBRAYA vaccine 0.5 ML Injection

RxCUI
2670566
RxNorm name
PENBRAYA vaccine 0.5 ML Injection
Display name
PENBRAYA vaccine 0.5 ML Injection
Full name
PENBRAYA vaccine 0.5 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:29

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125770PENBRAYAMeningococcal Groups A, B, C, W, and Y Vaccine351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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
fd5652b6-5ae4-437e-a456-47deaf500794PENBRAYA vaccine 0.5 ML Injection [PSN] · 0.5 ML Neisseria meningitidis serogroup A capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.01 MG/ML / Neisseria meningitidis serogroup B recombinant LP2086 A05 protein variant antigen 0.12 MG/ML / Neisseria meningitidis serogroup B recombinant LP2086 B01 protein variant antigen 0.12 MG/ML / Neisseria meningitidis serogroup C capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.01 MG/ML / Neisseria meningitidis serogroup W-135 capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.01 MG/ML / Neisseria meningitidis serogroup Y capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.01 MG/ML Injection [Penbraya] [SBD] · Penbraya (Neisseria meningitidis serogroup A capsular polysaccharide tetanus toxoid protein conjugate vaccine 5 MCG / Neisseria meningitidis serogroup B recombinant LP2086 A05 protein variant antigen 0.06 MG / Neisseria meningitidis serogroup B recombinant LP2086 B01 protein variant antigen 0.06 MG 410These highlights do not include all the information needed to use PENBRAYA safely and effectively. See full prescribing information for PENBRAYA. PENBRAYA ® (Meningococcal Groups A, B, C, W, and Y Vaccine), suspension for intramuscular injection Initial U.S. Approval: 202320260317