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  5. NDC Package Code: 49281-398-15 Fluzone Quadrivalent Southern Hemisphere

NDC Package 49281-398-15 Fluzone Quadrivalent Southern Hemisphere

Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
49281-398-15
Package Description:
1 VIAL, MULTI-DOSE in 1 PACKAGE / 5 mL in 1 VIAL, MULTI-DOSE (49281-398-78)
Product Code:
49281-398
Proprietary Name:
Fluzone Quadrivalent Southern Hemisphere
Non-Proprietary Name:
Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/california/122/2022 (a/thailand/8/2022-like Virus (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated), And Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated)
Substance Name:
Influenza A Virus A/california/122/2022 San-022 (h3n2) Antigen (formaldehyde Inactivated); Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated); Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated); Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated)
Usage Information:
Fluzone® Quadrivalent Southern Hemisphere is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.Fluzone Quadrivalent Southern Hemisphere is approved for use in persons 6 months of age and older.
11-Digit NDC Billing Format:
49281039815
NDC to RxNorm Crosswalk:
  • RxCUI: 2675669 - influenza virus vaccine 2024 (quadrivalent - California/Victoria/Michigan/Phuket) 0.5 ML Prefilled Syringe, southern hemisphere
  • RxCUI: 2675669 - 0.5 ML influenza A virus A/California/122/2022 (H3N2) antigen 0.03 MG/ML / influenza A virus A/Victoria/4897/2022 (H1N1) antigen 0.03 MG/ML / influenza B virus B/Michigan/01/2021 antigen 0.03 MG/ML / influenza B virus B/Phuket/3073/2013 antigen 0.03 MG/ML Prefilled Syringe
  • RxCUI: 2675672 - Fluzone Quadrivalent 2024 Southern Hemisphere vaccine 0.5 mL Prefilled Syringe
  • RxCUI: 2675672 - 0.5 ML influenza A virus A/California/122/2022 (H3N2) antigen 0.03 MG/ML / influenza A virus A/Victoria/4897/2022 (H1N1) antigen 0.03 MG/ML / influenza B virus B/Michigan/01/2021 antigen 0.03 MG/ML / influenza B virus B/Phuket/3073/2013 antigen 0.03 MG/ML Prefilled Syringe [Fluzone Quadrivalent 2024 Southern Hemisphere]
  • RxCUI: 2675675 - influenza virus vaccine 2024 (quadrivalent - California/Victoria/Michigan/Phuket) Injectable Suspension, southern hemisphere
    • Product Type:
    Vaccine
    Labeler Name:
    Sanofi Pasteur Inc.
    Dosage Form:
    Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
    Administration Route(s):
  • Intramuscular - Administration within a muscle.
    • Active Ingredient(s):
  • INFLUENZA A VIRUS A/CALIFORNIA/122/2022 SAN-022 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug/.5mL
  • INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug/.5mL
  • INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug/.5mL
  • INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug/.5mL
    • Sample Package:
    No
    FDA Application Number:
    BLA103914
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    02-14-2024
    End Marketing Date:
    12-31-2024
    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.

    Frequently Asked Questions

    What is NDC 49281-398-15?

    The NDC Packaged Code 49281-398-15 is assigned to a package of 1 vial, multi-dose in 1 package / 5 ml in 1 vial, multi-dose (49281-398-78) of Fluzone Quadrivalent Southern Hemisphere, a vaccine label labeled by Sanofi Pasteur Inc.. The product's dosage form is injection, suspension and is administered via intramuscular form.

    Is NDC 49281-398 included in the NDC Directory?

    Yes, Fluzone Quadrivalent Southern Hemisphere with product code 49281-398 is active and included in the NDC Directory. The product was first marketed by Sanofi Pasteur Inc. on February 14, 2024.

    What is the 11-digit format for NDC 49281-398-15?

    The 11-digit format is 49281039815. 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
    5-3-249281-398-155-4-249281-0398-15