Bexsero
NDC Package 46028-114-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Bexsero is this vaccine is used to help prevent certain serious, sometimes fatal, bacterial infections (meningitis, meningococcemia). Marketed by Novartis Vaccines And Diagnostics Srl, this product is identified by NDC 46028-114 and is authorized under FDA application BLA125546.

Identification & Billing

NDC Package Code
46028-114-01
Package Description
10 SYRINGE, GLASS in 1 BOX / .5 mL in 1 SYRINGE, GLASS (46028-114-11)
Product Code
46028-114
11-Digit Billing Format
46028011401
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Bexsero
Dosage Form
-
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
Novartis Vaccines And Diagnostics Srl
FDA Application #
BLA125546
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
01-23-2015
End Marketing Date
10-31-2017
Listing Expiration
10-31-2017
Exclude Flag
D
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (46028-114). Click a package code to view its specific billing and regulatory data.

46028-114-02
1 SYRINGE, GLASS in 1 BOX / .5 mL in 1 SYRINGE, GLASS (46028-114-11)

* 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 46028-114-01 identifies a specific commercial package of 10 syringe, glass in 1 box / .5 ml in 1 syringe, glass (46028-114-11) of Bexsero, labeled by Novartis Vaccines And Diagnostics Srl. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Novartis Vaccines And Diagnostics Srl on January 23, 2015. The current certification is valid through October 31, 2017.

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 Novartis Vaccines And Diagnostics Srl product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46028011401. 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)
46028-114-01
11-Digit CMS (5-4-2)
46028-0114-01

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