FDA.reportPublic FDA data

PENMENVY

Product NDC
58160-757
11-digit product format
581600757
Labeler code
58160
Product ID
58160-757_cd12af8c-e1a6-4d30-8861-8b0b923a446f
Type
VACCINE
Nonproprietary name
Meningococcal (Groups A, B, C, W and Y)
Dosage form
KIT
Labeler
GlaxoSmithKline Biologicals SA
Application
BLA125819
Marketing category
BLA
Marketing start
2025-02-14
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PENMENVY
Listing expiration
2027-12-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58160-730-03PENMENVY0.5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,5 mL5 ug in 0.5mL3
58160-750-03PENMENVY0.5 mL in 1 SYRINGESOLUTION5 mL50 ug in 0.5mL3
58160-757-15PENMENVY1 in 1 CARTONKIT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58160-757-15EA - Each58160-7571dd05b2c-6594-472e-867d-0ac18800423b12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58160-757PENMENVY (MENINGOCOCCAL (GROUPS A, B, C, W AND Y)) KIT [GLAXOSMITHKLINE BIOLOGICALS SA]1Current NDC, 3 package rows20250221_6b2c9ee3-ae88-46f1-9b3f-fc9e9e716cbf.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125819PENMENVYMeningococcal Groups A, B, C, W and Y Vaccine351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2705460Meningococcal (Groups A,B,C,Y and W-135) Polysaccharide Vaccine 0.5 ML InjectionPSN6b2c9ee3-ae88-46f1-9b3f-fc9e9e716cbf3
2705467PENMENVY vaccine 0.5 ML InjectionPSN6b2c9ee3-ae88-46f1-9b3f-fc9e9e716cbf3
27054670.5 ML Neisseria meningitidis serogroup A oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.02 MG/ML / Neisseria meningitidis serogroup B recombinant FHBP fusion protein antigen 0.1 MG/ML / Neisseria meningitidis serogroup B recombinant NADA fusion protein antigen 0.1 MG/ML / Neisseria meningitidis serogroup B recombinant NHBA fusion protein antigen 0.1 MG/ML / Neisseria meningitidis serogroup B strain NZ98/254 outer membrane vesicle 0.05 MG/ML / Neisseria meningitidis serogroup C oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.01 MG/ML / Neisseria meningitidis serogroup W-135 oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.01 MG/ML / Neisseria meningiSBD6b2c9ee3-ae88-46f1-9b3f-fc9e9e716cbf3
27054600.5 ML Neisseria meningitidis serogroup A oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.02 MG/ML / Neisseria meningitidis serogroup B recombinant FHBP fusion protein antigen 0.1 MG/ML / Neisseria meningitidis serogroup B recombinant NADA fusion protein antigen 0.1 MG/ML / Neisseria meningitidis serogroup B recombinant NHBA fusion protein antigen 0.1 MG/ML / Neisseria meningitidis serogroup B strain NZ98/254 outer membrane vesicle 0.05 MG/ML / Neisseria meningitidis serogroup C oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.01 MG/ML / Neisseria meningitidis serogroup W-135 oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.01 MG/ML / Neisseria meningiSCD6b2c9ee3-ae88-46f1-9b3f-fc9e9e716cbf3
2705460Neisseria meningitidis serogroup A oligosaccharide diphtheria CRM197 protein conjugate vaccine 10 MCG / Neisseria meningitidis serogroup B recombinant NHBA fusion protein antigen 50 MCG / Neisseria meningitidis serogroup B recombinant FHBP fusion protein antigen 50 MCG / Neisseria meningitidis serogroup B recombinant NADA fusion protein antigen 50 MCG / Neisseria meningitidis serogroup B strain NZ98/254 outer membrane vesicle 25 MCG / Neisseria meningitidis serogroup C oligosaccharide diphtheria CRM197 protein conjugate vaccine 5 MCG / Neisseria meningitidis serogroup W-135 oligosaccharide diphtheria CRM197 protein conjugate vaccine 5 MCG / Neisseria meningitidis serogroup Y oligosaccharide SY6b2c9ee3-ae88-46f1-9b3f-fc9e9e716cbf3
2705467Penmenvy (Neisseria meningitidis serogroup A oligosaccharide diphtheria CRM197 protein conjugate vaccine 10 MCG / Neisseria meningitidis serogroup B recombinant NHBA fusion protein antigen 50 MCG / Neisseria meningitidis serogroup B recombinant FHBP fusion protein antigen 50 MCG / Neisseria meningitidis serogroup B recombinant NADA fusion protein antigen 50 MCG / Neisseria meningitidis serogroup B strain NZ98/254 outer membrane vesicle 25 MCG / Neisseria meningitidis serogroup C oligosaccharide diphtheria CRM197 protein conjugate vaccine 5 MCG / Neisseria meningitidis serogroup W-135 oligosaccharide diphtheria CRM197 protein conjugate vaccine 5 MCG / Neisseria meningitidis serogroup Y oligosSY6b2c9ee3-ae88-46f1-9b3f-fc9e9e716cbf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58160-730-03581600730030.5 mL in 1 VIAL0.5 mlHistorical
58160-750-03581600750030.5 mL in 1 SYRINGE0.5 mlHistorical
58160-757-15581600757151 KIT in 1 CARTON (58160-757-15) * .5 mL in 1 VIAL (58160-730-03) * .5 mL in 1 SYRINGE (58160-750-03) 1 kit2025-02-14NoNoCurrent