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  5. NDC Package Code: 70461-123-03 Fluad Quadrivalent

NDC Package 70461-123-03 Fluad Quadrivalent

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:
70461-123-03
Package Description:
10 SYRINGE, GLASS in 1 CARTON / .5 mL in 1 SYRINGE, GLASS (70461-123-04)
Product Code:
70461-123
Proprietary Name:
Fluad Quadrivalent
Non-Proprietary Name:
Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/6/2021 Ivr-227 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/austria/1359417/2021 Bvr-26 Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (formaldehyde Inactivated)
Substance Name:
Influenza A Virus A/darwin/6/2021 Ivr-227 (h3n2) Antigen (formaldehyde Inactivated); Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated); Influenza B Virus B/austria/1359417/2021 Bvr-26 Antigen (formaldehyde Inactivated); Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (formaldehyde Inactivated)
Usage Information:
FLUAD QUADRIVALENT is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. FLUAD QUADRIVALENT is approved for use in persons 65 years of age and older. This indication is approved under accelerated approval based on the immune response elicited by FLUAD QUADRIVALENT [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
11-Digit NDC Billing Format:
70461012303
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2641626 - influenza virus vaccine 2023-2024 (quadrivalent - Darwin/6/Victoria/Austria/Phuket) 0.5 ML Prefilled Syringe
  • RxCUI: 2641626 - 0.5 ML influenza A virus A/Darwin/6/2021 (H3N2) antigen 0.03 MG/ML / influenza A virus A/Victoria/4897/2022 (H1N1) antigen 0.03 MG/ML / influenza B virus B/Austria/1359417/2021 antigen 0.03 MG/ML / influenza B virus B/Phuket/3073/2013 antigen 0.03 MG/ML Prefilled Syringe
  • RxCUI: 2641632 - FLUAD Quadrivalent 2023-2024 vaccine 0.5 ML Prefilled Syringe
  • RxCUI: 2641632 - 0.5 ML influenza A virus A/Darwin/6/2021 (H3N2) antigen 0.03 MG/ML / influenza A virus A/Victoria/4897/2022 (H1N1) antigen 0.03 MG/ML / influenza B virus B/Austria/1359417/2021 antigen 0.03 MG/ML / influenza B virus B/Phuket/3073/2013 antigen 0.03 MG/ML Prefilled Syringe [Fluad Quadrivalent 2023-2024]
  • RxCUI: 2641632 - Fluad Quadrivalent 2023-2024 vaccine 0.5 ML Prefilled Syringe
    • Product Type:
    Vaccine
    Labeler Name:
    Seqirus, 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/DARWIN/6/2021 IVR-227 (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/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug/.5mL
  • INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug/.5mL
    • Sample Package:
    No
    FDA Application Number:
    BLA125510
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    07-01-2023
    End Marketing Date:
    07-31-2024
    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 70461-123-03?

    The NDC Packaged Code 70461-123-03 is assigned to a package of 10 syringe, glass in 1 carton / .5 ml in 1 syringe, glass (70461-123-04) of Fluad Quadrivalent, a vaccine label labeled by Seqirus, Inc.. The product's dosage form is injection, suspension and is administered via intramuscular form.

    Is NDC 70461-123 included in the NDC Directory?

    Yes, Fluad Quadrivalent with product code 70461-123 is active and included in the NDC Directory. The product was first marketed by Seqirus, Inc. on July 01, 2023.

    What is the NDC billing unit for package 70461-123-03?

    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 70461-123-03?

    The 11-digit format is 70461012303. 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
    5-3-270461-123-035-4-270461-0123-03