Menactra Injection, Solution
NDC Package 49281-589-05

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

Package Information

Menactra (neisseria meningitidis group a capsular polysaccharide diphtheria toxoid conjugate antigen, neisseria meningitidis group c capsular polysaccharide diphtheria toxoid conjugate antigen, neisseria meningitidis group y capsular polysaccharide diphtheria toxoid conjugate antigen, and neisseria meningitidis group w-135 capsular polysaccharide diphtheria toxoid conjugate antigen) injection is this vaccine is used to help prevent certain serious, sometimes fatal, bacterial infections (meningitis, meningococcemia). This formulation utilizes a injection, solution delivery system. Marketed by Sanofi Vaccines Us Inc., this product is identified by NDC 49281-589 and is authorized under FDA application BLA125089.

Identification & Billing

NDC Package Code
49281-589-05
Package Description
5 VIAL, SINGLE-DOSE in 1 PACKAGE / .5 mL in 1 VIAL, SINGLE-DOSE (49281-589-58)
Product Code
49281-589
11-Digit Billing Format
49281058905
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 797638 - meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MCV4 generic for Menactra) 0.5 ML Injection
  • RxCUI: 797638 - 0.5 ML Neisseria meningitidis serogroup A capsular polysaccharide diphtheria toxoid protein conjugate vaccine 0.104 MG/ML / Neisseria meningitidis serogroup C capsular polysaccharide diphtheria toxoid protein conjugate vaccine 0.104 MG/ML / Neisseria meningitidis serogroup W-135 capsular polysaccharide diphtheria toxoid protein conjugate vaccine 0.104 MG/ML / Neisseria meningitidis serogroup Y capsular polysaccharide diphtheria toxoid protein conjugate vaccine 0.104 MG/ML Injection
  • RxCUI: 797638 - meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine 0.5 ML Injection
  • RxCUI: 797641 - Menactra vaccine 0.5 ML Injection
  • RxCUI: 797641 - 0.5 ML Neisseria meningitidis serogroup A capsular polysaccharide diphtheria toxoid protein conjugate vaccine 0.104 MG/ML / Neisseria meningitidis serogroup C capsular polysaccharide diphtheria toxoid protein conjugate vaccine 0.104 MG/ML / Neisseria meningitidis serogroup W-135 capsular polysaccharide diphtheria toxoid protein conjugate vaccine 0.104 MG/ML / Neisseria meningitidis serogroup Y capsular polysaccharide diphtheria toxoid protein conjugate vaccine 0.104 MG/ML Injection [Menactra]

Clinical Specifications

Proprietary Name
Menactra
Non-Proprietary Name
Neisseria Meningitidis Group A Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen, Neisseria Meningitidis Group C Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen, Neisseria Meningitidis Group Y Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen, And Neisseria Meningitidis Group W-135 Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen
Substance Name
Neisseria Meningitidis Group A Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen; Neisseria Meningitidis Group C Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen; Neisseria Meningitidis Group W-135 Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen; Neisseria Meningitidis Group Y Capsular Polysaccharide Diphtheria Toxoid 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
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
Sanofi Vaccines Us Inc.
Product Type
Vaccine
FDA Application #
BLA125089
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
01-14-2005
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 49281-589-05 identifies a specific commercial package of 5 vial, single-dose in 1 package / .5 ml in 1 vial, single-dose (49281-589-58) of Menactra, a vaccine label labeled by Sanofi Vaccines Us Inc.. This injection, solution is formulated for intramuscular use and contains neisseria meningitidis group a capsular polysaccharide diphtheria toxoid conjugate antigen; neisseria meningitidis group c capsular polysaccharide diphtheria toxoid conjugate antigen; neisseria meningitidis group w-135 capsular polysaccharide diphtheria toxoid conjugate antigen; neisseria meningitidis group y capsular polysaccharide diphtheria toxoid 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 Sanofi Vaccines Us Inc. on January 14, 2005. The current certification is valid through December 31, 2027.

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 Sanofi Vaccines Us Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49281058905. 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)
49281-589-05
11-Digit CMS (5-4-2)
49281-0589-05

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