Beyfortus Injection
NDC Package 49281-574-15

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

Beyfortus (nirsevimab) injection is bEYFORTUS is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in:•Neonates and infants born during or entering their first RSV season.•Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. This formulation utilizes a injection delivery system. Marketed by Sanofi Vaccines Us Inc., this product is identified by NDC 49281-574 and is authorized under FDA application BLA761328.

Identification & Billing

NDC Package Code
49281-574-15
Package Description
5 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE
Product Code
49281-574
11-Digit Billing Format
49281057415
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Beyfortus
Non-Proprietary Name
Nirsevimab
Substance Name
Nirsevimab
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
NIRSEVIMAB 100 mg/mL
Pharmacologic Class
Usage Information
BEYFORTUS is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in:•Neonates and infants born during or entering their first RSV season.•Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Regulatory & Marketing

Labeler Name
Sanofi Vaccines Us Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761328
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-18-2023
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 (49281-574). Click a package code to view its specific billing and regulatory data.

49281-574-88
1 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE

* 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 49281-574-15 identifies a specific commercial package of 5 syringe in 1 carton / 1 ml in 1 syringe of Beyfortus, a human prescription drug labeled by Sanofi Vaccines Us Inc.. This injection is formulated for intramuscular use and contains nirsevimab 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 July 18, 2023. 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: 49281057415. 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)
49281-574-15
11-Digit CMS (5-4-2)
49281-0574-15

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