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  5. NDC Package Code: 49281-574-15 Beyfortus

NDC Package 49281-574-15 Beyfortus

Nirsevimab Injection Intramuscular - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
49281-574-15
Package Description:
5 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE
Product Code:
49281-574
Proprietary Name:
Beyfortus
Non-Proprietary Name:
Nirsevimab
Substance Name:
Nirsevimab
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.
11-Digit NDC Billing Format:
49281057415
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2642406 - nirsevimab-alip 50 MG in 0.5 ML Prefilled Syringe
  • RxCUI: 2642406 - 0.5 ML nirsevimab-alip 100 MG/ML Prefilled Syringe
  • RxCUI: 2642406 - nirsevimab-alip 50 MG per 0.5 ML Prefilled Syringe
  • RxCUI: 2642412 - Beyfortus 50 MG in 0.5 ML Prefilled Syringe
  • RxCUI: 2642412 - 0.5 ML nirsevimab-alip 100 MG/ML Prefilled Syringe [Beyfortus]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sanofi Pasteur Inc.
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Intramuscular - Administration within a muscle.
    • Active Ingredient(s):
  • NIRSEVIMAB 100 mg/mL
    • Pharmacologic Class(es):
  • Fusion Protein Inhibitors - [MoA] (Mechanism of Action)
  • Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    BLA761328
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    07-18-2023
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    49281-574-881 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 49281-574-15?

    The NDC Packaged Code 49281-574-15 is assigned to a package of 5 syringe in 1 carton / .5 ml in 1 syringe of Beyfortus, a human prescription drug labeled by Sanofi Pasteur Inc.. The product's dosage form is injection and is administered via intramuscular form.

    Is NDC 49281-574 included in the NDC Directory?

    Yes, Beyfortus with product code 49281-574 is active and included in the NDC Directory. The product was first marketed by Sanofi Pasteur Inc. on July 18, 2023 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 49281-574-15?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 49281-574-15?

    The 11-digit format is 49281057415. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-249281-574-155-4-249281-0574-15