Menquadfi Injection, Solution
NDC Package 49281-590-01

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

Menquadfi (neisseria meningitidis group a capsular polysaccharide tetanus toxoid conjugate antigen, neisseria meningitidis group c capsular polysaccharide tetanus toxoid conjugate antigen, neisseria meningitidis group y capsular polysaccharide tetanus toxoid conjugate antigen, and neisseria meningitidis group w-135 capsular polysaccharide tetanus toxoid conjugate antigen) injection is menQuadfi™ is a vaccine indicated for active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. This formulation utilizes a injection, solution delivery system. Marketed by Sanofi Vaccines Us Inc., this product is identified by NDC 49281-590 and is authorized under FDA application BLA125701.

Identification & Billing

NDC Package Code
49281-590-01
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE (49281-590-58)
Product Code
49281-590
11-Digit Billing Format
49281059001
RxNorm Crosswalk
  • RxCUI: 2360583 - meningococcal (groups A, C, Y and W-135) polysaccharide tetanus toxoid conjugate vaccine 0.5 ML Injection
  • RxCUI: 2360583 - 0.5 ML Neisseria meningitidis serogroup A capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.02 MG/ML / Neisseria meningitidis serogroup C capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.02 MG/ML / Neisseria meningitidis serogroup W-135 capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.02 MG/ML / Neisseria meningitidis serogroup Y capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.02 MG/ML Injection
  • RxCUI: 2360588 - MenQuadfi vaccine 0.5 ML Injection
  • RxCUI: 2360588 - 0.5 ML Neisseria meningitidis serogroup A capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.02 MG/ML / Neisseria meningitidis serogroup C capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.02 MG/ML / Neisseria meningitidis serogroup W-135 capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.02 MG/ML / Neisseria meningitidis serogroup Y capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.02 MG/ML Injection [Menquadfi]
  • RxCUI: 2360588 - MenQuadfi Meningococcal (Groups A,C,Y and W-135) Polysaccharide Tetanus Toxoid Conjugate Vaccine 0.5 ML Injection

Clinical Specifications

Proprietary Name
Menquadfi
Non-Proprietary Name
Neisseria Meningitidis Group A Capsular Polysaccharide Tetanus Toxoid Conjugate Antigen, Neisseria Meningitidis Group C Capsular Polysaccharide Tetanus Toxoid Conjugate Antigen, Neisseria Meningitidis Group Y Capsular Polysaccharide Tetanus Toxoid Conjugate Antigen, And Neisseria Meningitidis Group W-135 Capsular Polysaccharide Tetanus Toxoid Conjugate Antigen
Substance Name
Neisseria Meningitidis Group A Capsular Polysaccharide Tetanus Toxoid Conjugate Antigen; Neisseria Meningitidis Group C Capsular Polysaccharide Tetanus Toxoid Conjugate Antigen; Neisseria Meningitidis Group W-135 Capsular Polysaccharide Tetanus Toxoid Conjugate Antigen; Neisseria Meningitidis Group Y Capsular Polysaccharide Tetanus 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)
Usage Information
MenQuadfi™ is a vaccine indicated for active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. MenQuadfi is indicated for use in individuals 2 years of age and older.MenQuadfi does not prevent N. meningitidis serogroup B disease.

Regulatory & Marketing

Labeler Name
Sanofi Vaccines Us Inc.
Product Type
Vaccine
FDA Application #
BLA125701
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
04-23-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (49281-590). Click a package code to view its specific billing and regulatory data.

49281-590-05
5 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE (49281-590-58)
49281-590-10
10 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE (49281-590-58)

* 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 49281-590-01 identifies a specific commercial package of 1 vial, single-dose in 1 carton / .5 ml in 1 vial, single-dose (49281-590-58) of Menquadfi, 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 tetanus toxoid conjugate antigen; neisseria meningitidis group c capsular polysaccharide tetanus toxoid conjugate antigen; neisseria meningitidis group w-135 capsular polysaccharide tetanus toxoid conjugate antigen; neisseria meningitidis group y capsular polysaccharide tetanus 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 April 23, 2020. The current certification is valid through December 31, 2027.

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: 49281059001. 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)
49281-590-01
11-Digit CMS (5-4-2)
49281-0590-01

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