NDC Code(s) : 58160-976-02, 58160-976-20
Packager : GlaxoSmithKline Biologicals SA

Category : VACCINE LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BexseroNEISSERIA 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
Product Information
Product Type VACCINE Item Code (Source) NDC:58160-976
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN ANTIGEN(UNII: 28E911Y7AE)
(NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN ANTIGEN - UNII:28E911Y7AE) 		NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN ANTIGEN50 ug in 0.5 mL
NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN ANTIGEN(UNII: 25DB599G64)
(NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN ANTIGEN - UNII:25DB599G64) 		NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN ANTIGEN50 ug in 0.5 mL
NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN ANTIGEN(UNII: 1S25R442RS)
(NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN ANTIGEN - UNII:1S25R442RS) 		NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN ANTIGEN50 ug in 0.5 mL
NEISSERIA MENINGITIDIS GROUP B STRAIN NZ98/254 OUTER MEMBRANE VESICLE ANTIGEN(UNII: 91523M4S24)
(NEISSERIA MENINGITIDIS GROUP B STRAIN NZ98/254 OUTER MEMBRANE VESICLE ANTIGEN - UNII:91523M4S24) 		NEISSERIA MENINGITIDIS GROUP B STRAIN NZ98/254 OUTER MEMBRANE VESICLE ANTIGEN25 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
HISTIDINE(UNII: 4QD397987E)
SUCROSE(UNII: C151H8M554)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58160-976-2010 in 1 CARTON
1NDC:58160-976-020.5 mL in 1 SYRINGE Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125546 12/01/2016

LABELER - GlaxoSmithKline Biologicals SA(372748392)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 58160-976-20

BEXSERO

Meningococcal Group B Vaccine

MenB

GSK

Rx Only

For Use from 10 through 25 Years of Age

10 Disposable Single-Dose Prefilled TIP-LOK Syringes each containing one 0.5-mL dose

TIP-LOK syringes to be used with Luer Lock compatible needles

NEEDLES NOT INCLUDED

BEXSERO

Made in Italy

©2023 GSK group of companies or its licensor.

  •  Rev. 08/23
  •  515763
  •   Bexsero 10 count syringe carton

PRINCIPAL DISPLAY PANEL

Syringe Label

NDC 58160-976-02

503001

Bexsero syringe label