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  5. NDC Package Code: 70461-423-10 Flucelvax Quadrivalent

NDC Package 70461-423-10 Flucelvax Quadrivalent

Influenza A Virus A/georgia/12/2022 Crv-167 (h1n1) Antigen (mdck Cell - 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:
70461-423-10
Package Description:
1 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE (70461-423-11)
Product Code:
70461-423
Proprietary Name:
Flucelvax Quadrivalent
Non-Proprietary Name:
Influenza A Virus A/georgia/12/2022 Crv-167 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza A Virus A/darwin/11/2021 (h3n2) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/singapore/wuh4618/2021 Antigen (mdck Cell Derived, Ropiolactone Inactivated), Influenza B Virus B/singapore/inftt-16-0610/2016 Antigen (mdck Cell Derived, Propiolactone Inactivated)
Substance Name:
Influenza A Virus A/darwin/11/2021 (h3n2) Antigen (mdck Cell Derived, Propiolactone Inactivated); Influenza A Virus A/georgia/12/2022 Cvr-167 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated); Influenza B Virus B/singapore/inftt-16-0610/2016 Antigen (mdck Cell Derived, Propiolactone Inactivated); Influenza B Virus B/singapore/wuh4618/2021 Antigen (mdck Cell Derived, Propiolactone Inactivated)
Usage Information:
FLUCELVAX QUADRIVALENT is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. FLUCELVAX QUADRIVALENT is approved for use in persons 6 months of age and older. [see Clinical Studies (14)]
11-Digit NDC Billing Format:
70461042310
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2641879 - influenza virus vaccine 2023-2024 (quadrivalent - Darwin/Georgia/Singapore INFTT-16-0610/Singapore WUH4618) Injectable Suspension
  • RxCUI: 2641879 - influenza A virus A/Darwin/11/2021 (H3N2) antigen 0.03 MG/ML / influenza A virus A/Georgia/12/2022 (H1N1) antigen 0.03 MG/ML / influenza B virus B/Singapore/INFTT-16-0610/2016 antigen 0.03 MG/ML / influenza B virus B/Singapore/WUH4618/2021 antigen 0.03 MG/ML Injectable Suspension
  • RxCUI: 2641884 - FLUCELVAX Quadrivalent 2023-2024 vaccine Injectable Suspension
  • RxCUI: 2641884 - influenza A virus A/Darwin/11/2021 (H3N2) antigen 0.03 MG/ML / influenza A virus A/Georgia/12/2022 (H1N1) antigen 0.03 MG/ML / influenza B virus B/Singapore/INFTT-16-0610/2016 antigen 0.03 MG/ML / influenza B virus B/Singapore/WUH4618/2021 antigen 0.03 MG/ML Injectable Suspension [Flucelvax Quadrivalent 2023-2024]
  • RxCUI: 2641884 - Flucelvax Quadrivalent 2023-2024 vaccine Injectable Suspension
    • 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/11/2021 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15 ug/.5mL
  • INFLUENZA A VIRUS A/GEORGIA/12/2022 CVR-167 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15 ug/.5mL
  • INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15 ug/.5mL
  • INFLUENZA B VIRUS B/SINGAPORE/WUH4618/2021 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15 ug/.5mL
    • Sample Package:
    No
    FDA Application Number:
    BLA125408
    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 70461-423-10?

    The NDC Packaged Code 70461-423-10 is assigned to a package of 1 vial, multi-dose in 1 carton / 5 ml in 1 vial, multi-dose (70461-423-11) of Flucelvax Quadrivalent, a vaccine label labeled by Seqirus Inc.. The product's dosage form is injection, suspension and is administered via intramuscular form.

    Is NDC 70461-423 included in the NDC Directory?

    Yes, Flucelvax Quadrivalent with product code 70461-423 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 70461-423-10?

    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 70461-423-10?

    The 11-digit format is 70461042310. 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
    5-3-270461-423-105-4-270461-0423-10