Bexsero Injection, Suspension
NDC Package 58160-976-20

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package 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) injection is this vaccine is used to help prevent certain serious, sometimes fatal, bacterial infections (meningitis, meningococcemia). This formulation utilizes a injection, suspension delivery system. Marketed by Glaxosmithkline Biologicals Sa, this product is identified by NDC 58160-976 and is authorized under FDA application BLA125546.

Identification & Billing

NDC Package Code
58160-976-20
Package Description
10 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE (58160-976-02)
Product Code
58160-976
11-Digit Billing Format
58160097620
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • 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]

Clinical Specifications

Proprietary Name
Bexsero
Non-Proprietary 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
Substance Name
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
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
Intramuscular - Administration within a muscle.
Active Ingredient(s)
Usage Information
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.

Regulatory & Marketing

Labeler Name
Glaxosmithkline Biologicals Sa
Product Type
Vaccine
FDA Application #
BLA125546
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-01-2016
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 58160-976-20 identifies a specific commercial package of 10 syringe in 1 carton / .5 ml in 1 syringe (58160-976-02) of Bexsero, a vaccine label labeled by Glaxosmithkline Biologicals Sa. This injection, suspension is formulated for intramuscular use and contains 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 as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Glaxosmithkline Biologicals Sa on December 01, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Glaxosmithkline Biologicals Sa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58160097620. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
58160-976-20
11-Digit CMS (5-4-2)
58160-0976-20

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.