Menveo Injection, Solution
NDC Package 58160-827-30

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

Package Information

Menveo (meningococcal (groups a, c, y and w-135) oligosaccharide diphtheria crm197 conjugate vaccine) injection is mENVEO is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. This formulation utilizes a injection, solution delivery system. Marketed by Glaxosmithkline Biologicals Sa, this product is identified by NDC 58160-827 and is authorized under FDA application BLA125300.

Identification & Billing

NDC Package Code
58160-827-30
Package Description
10 VIAL in 1 CARTON / .5 mL in 1 VIAL (58160-827-03)
Product Code
58160-827
11-Digit Billing Format
58160082730
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 901514 - meningococcal (groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine (MCV4 generic for Menveo) 0.5 ML Injection
  • RxCUI: 901514 - 0.5 ML Neisseria meningitidis serogroup A oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.02 MG/ML / Neisseria meningitidis serogroup C oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.01 MG/ML / Neisseria meningitidis serogroup W-135 oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.01 MG/ML / Neisseria meningitidis serogroup Y oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.01 MG/ML Injection
  • RxCUI: 901514 - meningococcal (groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine 0.5 ML Injection
  • RxCUI: 901518 - MENVEO vaccine 0.5 ML Injection
  • RxCUI: 901518 - 0.5 ML Neisseria meningitidis serogroup A oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.02 MG/ML / Neisseria meningitidis serogroup C oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.01 MG/ML / Neisseria meningitidis serogroup W-135 oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.01 MG/ML / Neisseria meningitidis serogroup Y oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.01 MG/ML Injection [Menveo]

Clinical Specifications

Proprietary Name
Menveo
Non-Proprietary Name
Meningococcal (groups A, C, Y And W-135) Oligosaccharide Diphtheria Crm197 Conjugate Vaccine
Substance Name
Neisseria Meningitidis Group A Capsular Oligosaccharide Diphtheria Crm197 Protein Conjugate Antigen; Neisseria Meningitidis Group C Capsular Oligosaccharide Diphtheria Crm197 Protein Conjugate Antigen; Neisseria Meningitidis Group W-135 Capsular Oligosaccharide Diphtheria Crm197 Protein Conjugate Antigen; Neisseria Meningitidis Group Y Capsular Oligosaccharide Diphtheria Crm197 Protein Conjugate Antigen
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
Pharmacologic Class
Usage Information
MENVEO is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. MENVEO is approved for use in persons aged 2 months through 55 years.MENVEO does not prevent N. meningitidis serogroup B infections.

Regulatory & Marketing

Labeler Name
Glaxosmithkline Biologicals Sa
Product Type
Vaccine
FDA Application #
BLA125300
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-09-2022
Listing Expiration
12-31-2027
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 58160-827-30 identifies a specific commercial package of 10 vial in 1 carton / .5 ml in 1 vial (58160-827-03) of Menveo, a vaccine label labeled by Glaxosmithkline Biologicals Sa. This injection, solution is formulated for intramuscular use and contains neisseria meningitidis group a capsular oligosaccharide diphtheria crm197 protein conjugate antigen; neisseria meningitidis group c capsular oligosaccharide diphtheria crm197 protein conjugate antigen; neisseria meningitidis group w-135 capsular oligosaccharide diphtheria crm197 protein conjugate antigen; neisseria meningitidis group y capsular oligosaccharide diphtheria crm197 protein conjugate 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 09, 2022. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58160082730. 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)
58160-827-30
11-Digit CMS (5-4-2)
58160-0827-30

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