Bexsero Injection, Suspension
NDC 58160-976

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 58160-976?
  4. Bexsero Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

Bexsero (neisseria meningitidis serogroup b nhba fusion protein antigen, neisseria meningitidis serogroup b fhbp fusion protein antigen and neisseria meningitidis serogroup b nada protein antigen) is a BLA-approved product labeled by Glaxosmithkline Biologicals Sa. This vaccine is used to help prevent certain serious, sometimes fatal, bacterial infections (meningitis, meningococcemia). It is supplied as a injection, suspension for intramuscular administration. This product entry covers the primary NDC 58160-976 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
58160-976
Proprietary Name:
Bexsero
Non-Proprietary Name: [1]
Neisseria Meningitidis Serogroup B Nhba Fusion Protein Antigen, Neisseria Meningitidis Serogroup B Fhbp Fusion Protein Antigen And Neisseria Meningitidis Serogroup B Nada Protein Antigen
Substance Name: [2]
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
NDC Directory Status:
Vaccine
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route(s): [4]
Intramuscular - Administration within a muscle.

Labeler & Regulatory Data

Labeler Name: [5]
Glaxosmithkline Biologicals Sa
Labeler Code:
58160
Product Label ID:
f70cf2fc-6e6d-4a74-9f7a-db8fec072fd7
FDA Application Number: [6]
BLA125546
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
12-01-2016
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 58160-976?

The NDC code 58160-976 is assigned by the FDA to the product Bexsero. It is commonly known by its generic 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. This pharmaceutical product is labeled by Glaxosmithkline Biologicals Sa and is currently categorized as listed product. The medication is a injection, suspension administered via intramuscular route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 58160-976-20. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

This vaccine is used to help prevent certain serious, sometimes fatal, bacterial infections (meningitis, meningococcemia). This infection may cause severe problems (hearing loss, brain/nerve problems, paralysis, blindness, seizures, loss of limbs) even with antibiotic treatment. This vaccine works by increasing the body's natural defense (immunity) against the bacteria that cause meningococcal disease. Vaccination is the best way to prevent infection. However, like any vaccine, it may not fully protect everyone who receives it. The brand and dose of vaccine you receive depend on your age. Other vaccines may also be given at the same time, usually in a different site on the body.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

  • NEISSERIA MENINGITIDIS SEROGROUP B NHBA FUSION PROTEIN ANTIGEN (UNII: 28E911Y7AE)
  • NEISSERIA MENINGITIDIS SEROGROUP B NHBA FUSION PROTEIN ANTIGEN (UNII: 28E911Y7AE) (Active Moiety)
  • NEISSERIA MENINGITIDIS SEROGROUP B FHBP FUSION PROTEIN ANTIGEN (UNII: 25DB599G64)
  • NEISSERIA MENINGITIDIS SEROGROUP B FHBP FUSION PROTEIN ANTIGEN (UNII: 25DB599G64) (Active Moiety)
  • NEISSERIA MENINGITIDIS SEROGROUP B NADA PROTEIN ANTIGEN (UNII: 1S25R442RS)
  • NEISSERIA MENINGITIDIS SEROGROUP B NADA PROTEIN ANTIGEN (UNII: 1S25R442RS) (Active Moiety)
  • NEISSERIA MENINGITIDIS SEROGROUP B STRAIN NZ98/254 OUTER MEMBRANE VESICLE (UNII: 91523M4S24)
  • NEISSERIA MENINGITIDIS SEROGROUP B STRAIN NZ98/254 OUTER MEMBRANE VESICLE (UNII: 91523M4S24) (Active Moiety)

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1601402 - meningococcal group B vaccine (MenB generic for Bexsero) 0.5 ML Prefilled Syringe
  • RxCUI: 1601402 - 0.5 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
  • RxCUI: 1601402 - 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 Syringe
  • RxCUI: 1601407 - BEXSERO vaccine 0.5 ML Prefilled Syringe
  • RxCUI: 1601407 - 0.5 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]

* Please review the full disclaimer at the bottom of this page.

Patient Education

Serogroup B Meningococcal Vaccine (MenB)


Why get vaccinated? Meningococcal B vaccine can help protect against meningococcal disease caused by serogroup B. A different meningococcal vaccine is available that can help protect against serogroups A, C, W, and Y. Meningococcal disease can cause meningitis (infection of the lining of the brain and spinal cord) and infections of the blood. Even when it is treated, meningococcal disease kills 10 to 15 infected people out of 100. And of those who survive, about 10 to 20 out of every 100 will suffer disabilities such as hearing loss, brain damage, kidney damage, loss of limbs, nervous system problems, or severe scars from skin grafts. Meningococcal disease is rare and has declined in the United States since the 1990s. However, it is a severe disease with a significant risk of death or lasting disabilities in people who get it. Anyone can get meningococcal disease. Certain people are at increased risk, including: Infants younger than one year old Adolescents and young adults 16 through 23 years old People with certain medical conditions that affect the immune system Microbiologists who routinely work with isolates of N. meningitidis, the bacteria that cause meningococcal disease People at risk because of an outbreak in their community
[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".