1. Home
  2. Labeler Index
  3. Sanofi Pasteur Inc.
  4. 49281-403
  5. NDC Package Code: 49281-403-65 Fluzone High-dose

NDC Package 49281-403-65 Fluzone High-dose

Influenza A Virus A/michigan/45/2015 X-275 (h1n1) Antigen (formaldehyde - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    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:
49281-403-65
Package Description:
10 SYRINGE, GLASS in 1 PACKAGE / .5 mL in 1 SYRINGE, GLASS (49281-403-88)
Product Code:
49281-403
Proprietary Name:
Fluzone High-dose
Non-Proprietary Name:
Influenza A Virus A/michigan/45/2015 X-275 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/maryland/15/2016 Bx-69a (a B/colorado/6/2017-like Virus) Antigen (formaldehyde Inactivated)
Substance Name:
Influenza A Virus A/michigan/45/2015 X-275 (h1n1) Antigen (formaldehyde Inactivated); Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (formaldehyde Inactivated); Influenza B Virus B/maryland/15/2016 Bx-69a Antigen (formaldehyde Inactivated)
Usage Information:
Fluzone® High-Dose is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine.Fluzone High-Dose is approved for use in persons 65 years of age and older.
11-Digit NDC Billing Format:
49281040365
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2050418 - influenza virus vaccine 2018-2019 (trivalent - Michigan/Singapore/Maryland) 0.5 ML Prefilled Syringe
  • RxCUI: 2050418 - 0.5 ML influenza A virus A/Michigan/45/2015 (H1N1) antigen 0.12 MG/ML / influenza A virus A/Singapore/INFIMH-16-0019/2016 (H3N2) antigen 0.12 MG/ML / influenza B virus B/Maryland/15/2016 antigen 0.12 MG/ML Prefilled Syringe
  • RxCUI: 2050423 - Fluzone 2018-2019 high-dose vaccine 0.5 ML Prefilled Syringe
  • RxCUI: 2050423 - 0.5 ML influenza A virus A/Michigan/45/2015 (H1N1) antigen 0.12 MG/ML / influenza A virus A/Singapore/INFIMH-16-0019/2016 (H3N2) antigen 0.12 MG/ML / influenza B virus B/Maryland/15/2016 antigen 0.12 MG/ML Prefilled Syringe [Fluzone 2018-2019]
  • RxCUI: 2177692 - influenza virus vaccine 2019-2020 high-dose (trivalent - Brisbane/Kansas/Maryland) 0.5 mL Prefilled Syringe
    • 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/MICHIGAN/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) 60 ug/.5mL
  • INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) 60 ug/.5mL
  • INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED) 60 ug/.5mL
    • Sample Package:
    No
    FDA Application Number:
    BLA103914
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    06-29-2018
    Listing Expiration 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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 49281-403-65 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    4928104036590662Iiv no prsv increased ag im0.7 ML0.710110

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 49281-403-65?

    The NDC Packaged Code 49281-403-65 is assigned to a package of 10 syringe, glass in 1 package / .5 ml in 1 syringe, glass (49281-403-88) of Fluzone High-dose, a vaccine label labeled by Sanofi Pasteur Inc.. The product's dosage form is injection, suspension and is administered via intramuscular form.

    Is NDC 49281-403 included in the NDC Directory?

    Yes, Fluzone High-dose with product code 49281-403 is active and included in the NDC Directory. The product was first marketed by Sanofi Pasteur Inc. on June 29, 2018 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 49281-403-65?

    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 49281-403-65?

    The 11-digit format is 49281040365. 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
    5-3-249281-403-655-4-249281-0403-65