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  5. NDC Package Code: 49281-400-10 Adacel Tdap

NDC Package 49281-400-10 Adacel Tdap

Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated),Corynebacterium Diphtheriae - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. 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:
49281-400-10
Package Description:
10 VIAL in 1 PACKAGE / .5 mL in 1 VIAL (49281-400-58)
Product Code:
49281-400
Proprietary Name:
Adacel Tdap
Non-Proprietary Name:
Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated), Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated), Bordetella Pertussis Toxoid Antigen (glutaraldehyde Inactivated), Bordetella Pertussis Filamentous Hemagglutinin Antigen (formaldehyde Inactivated), Bordetella Pertussis Pertactin Antigen, And Bordetella Pertussis Fimbriae 2/3 Antigen
Substance Name:
Bordetella Pertussis Filamentous Hemagglutinin Antigen (formaldehyde Inactivated); Bordetella Pertussis Fimbriae 2/3 Antigen; Bordetella Pertussis Pertactin Antigen; Bordetella Pertussis Toxoid Antigen (glutaraldehyde Inactivated); Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated); Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated)
Usage Information:
This vaccine is used to keep up protection (immunity) against diphtheria, tetanus (lockjaw) and pertussis (whooping cough) in children and adults who have been vaccinated for these diseases in the past. Vaccination is the best way to protect against these life-threatening diseases. Vaccines work by causing the body to produce its own protection (antibodies). Booster doses are needed to keep up immunity because antibody levels may become too low over time to provide the needed protection.
11-Digit NDC Billing Format:
49281040010
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1300189 - tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (generic for Adacel) 0.5 ML Prefilled Syringe
  • RxCUI: 1300189 - 0.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.01 MG/ML / Bordetella pertussis fimbriae 2/3 vaccine, inactivated 0.01 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.006 MG/ML / Bordetella pertussis toxoid vaccine, inactivated 0.005 MG/ML / diphtheria toxoid vaccine, inactivated 4 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Prefilled Syringe
  • RxCUI: 1300189 - Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 5 MCG / Bordetella pertussis fimbriae 2/3 vaccine, inactivated 5 MCG / Bordetella pertussis pertactin vaccine, inactivated 3 MCG / Bordetella pertussis toxoid vaccine, inactivated 2.5 MCG / diphtheria toxoid vaccine, inactivated 2 UNT / tetanus toxoid vaccine, inactivated 5 UNT per 0.5 ML Prefilled Syringe
  • RxCUI: 1300189 - Tdap (tetanus toxoid vaccine, inactivated 5 UNT / diphtheria toxoid vaccine, inactivated 2 UNT / acellular pertussis vaccine 15.5 MCG) per 0.5 ML Prefilled Syringe
  • RxCUI: 1300191 - Adacel 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):
  • BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 5 ug/.5mL
  • BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN 5 ug/.5mL
  • BORDETELLA PERTUSSIS PERTACTIN ANTIGEN 3 ug/.5mL
  • BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) 2.5 ug/.5mL
  • CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 5 [Lf]/.5mL
  • CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 2 [Lf]/.5mL
    • Pharmacologic Class(es):
  • Actively Acquired Immunity - [PE] (Physiologic Effect)
  • Actively Acquired Immunity - [PE] (Physiologic Effect)
  • Diphtheria Toxoid - [CS]
  • Inactivated Bordetella Pertussis Vaccine - [EPC] (Established Pharmacologic Class)
  • Inactivated Clostridium Tetani Vaccine - [EPC] (Established Pharmacologic Class)
  • Inactivated Corynebacterium Diphtheriae Vaccine - [EPC] (Established Pharmacologic Class)
  • Pertussis Vaccine - [CS]
  • Tetanus Toxoid - [CS]
  • Vaccines, Inactivated - [CS]
    • Sample Package:
    No
    FDA Application Number:
    BLA125111
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    06-10-2005
    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 49281-400-10 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    4928104001090715Tdap vaccine 7 yrs/> im0.5 ML0.510110

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    49281-400-055 VIAL in 1 PACKAGE / .5 mL in 1 VIAL (49281-400-58)
    49281-400-205 SYRINGE in 1 PACKAGE / .5 mL in 1 SYRINGE (49281-400-89)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 49281-400-10?

    The NDC Packaged Code 49281-400-10 is assigned to a package of 10 vial in 1 package / .5 ml in 1 vial (49281-400-58) of Adacel Tdap, a vaccine label labeled by Sanofi Pasteur Inc.. The product's dosage form is injection, suspension and is administered via intramuscular form.

    Is NDC 49281-400 included in the NDC Directory?

    Yes, Adacel Tdap with product code 49281-400 is active and included in the NDC Directory. The product was first marketed by Sanofi Pasteur Inc. on June 10, 2005 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 49281-400-10?

    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 49281-400-10?

    The 11-digit format is 49281040010. 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
    5-3-249281-400-105-4-249281-0400-10