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  5. NDC Package Code: 58160-976-20 Bexsero

NDC Package 58160-976-20 Bexsero

Neisseria Meningitidis Serogroup B Nhba Fusion Protein Antigen,Neisseria Meningitidis - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
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
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.
11-Digit NDC Billing Format:
58160097620
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to 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]
    • Product Type:
    Vaccine
    Labeler Name:
    Glaxosmithkline Biologicals Sa
    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):
  • Intramuscular - Administration within a muscle.
    • Active Ingredient(s):
  • NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN ANTIGEN 50 ug/.5mL
  • NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN ANTIGEN 50 ug/.5mL
  • NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN ANTIGEN 50 ug/.5mL
  • NEISSERIA MENINGITIDIS GROUP B STRAIN NZ98/254 OUTER MEMBRANE VESICLE ANTIGEN 25 ug/.5mL
    • Sample Package:
    No
    FDA Application Number:
    BLA125546
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    12-01-2016
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 58160-976-20?

    The NDC Packaged Code 58160-976-20 is assigned to a 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. The product's dosage form is injection, suspension and is administered via intramuscular form.

    Is NDC 58160-976 included in the NDC Directory?

    Yes, Bexsero with product code 58160-976 is active and included in the NDC Directory. The product was first marketed by Glaxosmithkline Biologicals Sa on December 01, 2016 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 58160-976-20?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 58160-976-20?

    The 11-digit format is 58160097620. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-258160-976-205-4-258160-0976-20