FDA.reportPublic FDA data

Bexsero

Product NDC
58160-976
11-digit product format
581600976
Labeler code
58160
Product ID
58160-976_db17d990-e6e2-450c-b9ed-923ec92df84d
Type
VACCINE
Nonproprietary name
NEISSERIA MENINGITIDIS SEROGROUP B NHBA FUSION PROTEIN ANTIGEN, NEISSERIA MENINGITIDIS SEROGROUP B FHBP FUSION PROTEIN ANTIGEN and NEISSERIA MENINGITIDIS SEROGROUP B NADA PROTEIN ANTIGEN
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
GlaxoSmithKline Biologicals SA
Application
BLA125546
Marketing category
BLA
Marketing start
2016-12-01
Substance
NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN ANTIGEN; NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN ANTIGEN; NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN ANTIGEN; NEISSERIA MENINGITIDIS GROUP B STRAIN NZ98/254 OUTER MEMBRANE VESICLE ANTIGEN
Active strength
50; 50; 50; 25 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bexsero
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN ANTIGEN50 ug/.5mL
NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN ANTIGEN50 ug/.5mL
NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN ANTIGEN50 ug/.5mL
NEISSERIA MENINGITIDIS GROUP B STRAIN NZ98/254 OUTER MEMBRANE VESICLE ANTIGEN25 ug/.5mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58160-976-02Bexsero0.5 mL in 1 SYRINGEINJECTION, SUSPENSION0.511
58160-976-20Bexsero10 in 1 CARTONINJECTION, SUSPENSION1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58160-976-02ML - Milliliter58160-976ea8b3953-cb81-40cc-a036-d023bcd170eb12018-05-09
58160-976-06ML - Milliliter58160-976fe16154a-c308-45d7-b5e5-23d73218dcb012016-12-07
58160-976-20ML - Milliliter58160-976b1857e13-deeb-4957-9efb-060d41a6a39e12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58160-976BEXSERO (NEISSERIA MENINGITIDIS SEROGROUP B NHBA FUSION PROTEIN ANTIGEN, NEISSERIA MENINGITIDIS SEROGROUP B FHBP FUSION PROTEIN ANTIGEN AND NEISSERIA MENINGITIDIS SEROGROUP B NADA PROTEIN ANTIGEN) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]10Current NDC, Legacy NDC, 2 package rows20240828_f70cf2fc-6e6d-4a74-9f7a-db8fec072fd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1601407BEXSERO vaccine 0.5 ML Prefilled SyringePSNf70cf2fc-6e6d-4a74-9f7a-db8fec072fd711
1601402meningococcal group B vaccine (MenB generic for Bexsero) 0.5 ML Prefilled SyringePSNf70cf2fc-6e6d-4a74-9f7a-db8fec072fd711
16014070.5 ML meningococcal group B vaccine 0.1 MG/ML / Neisseria meningitidis serogroup B recombinant FHBP 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 Prefilled Syringe [Bexsero]SBDf70cf2fc-6e6d-4a74-9f7a-db8fec072fd711
16014020.5 ML meningococcal group B vaccine 0.1 MG/ML / Neisseria meningitidis serogroup B recombinant FHBP 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 Prefilled SyringeSCDf70cf2fc-6e6d-4a74-9f7a-db8fec072fd711
1601407Bexsero (meningococcal group B vaccine 0.1 MG/ML / Neisseria meningitidis serogroup B recombinant FHBP 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) per 0.5 ML Prefilled SyringeSYf70cf2fc-6e6d-4a74-9f7a-db8fec072fd711
1601407Bexsero (meningococcal group B vaccine 50 MCG / Neisseria meningitidis serogroup B recombinant FHBP fusion protein antigen 50 MCG / Neisseria meningitidis serogroup B recombinant NHBA fusion protein antigen 50 MCG / Neisseria meningitidis serogroup B strain NZ98/254 outer membrane vesicle 25 MCG) per 0.5 ML Prefilled SyringeSYf70cf2fc-6e6d-4a74-9f7a-db8fec072fd711
1601407Bexsero Meningococcal Group B Vaccine 0.5 ML Prefilled SyringeSYf70cf2fc-6e6d-4a74-9f7a-db8fec072fd711
1601402meningococcal group B vaccine 50 MCG / Neisseria meningitidis serogroup B recombinant FHBP fusion protein antigen 50 MCG / Neisseria meningitidis serogroup B recombinant NHBA fusion protein antigen 50 MCG / Neisseria meningitidis serogroup B strain NZ98/254 outer membrane vesicle 25 MCG per 0.5 ML Prefilled SyringeSYf70cf2fc-6e6d-4a74-9f7a-db8fec072fd711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58160-976-02581600976020.5 mL in 1 SYRINGE0.5 mlHistorical
58160-976-06581600976061 SYRINGE in 1 CARTON (58160-976-06) > .5 mL in 1 SYRINGE (58160-976-02) 1 syringe2016-12-010000-00-00NoNoCurrent
58160-976-205816009762010 SYRINGE in 1 CARTON (58160-976-20) / .5 mL in 1 SYRINGE (58160-976-02) 10 syringe2016-12-010000-00-00NoNoCurrent