NDC 49281-400-20 Adacel Tdap
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 Injection, Suspension Intramuscular

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

The table below has 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 49281-400-20
Package Description 5 SYRINGE in 1 PACKAGE / .5 mL in 1 SYRINGE (49281-400-89)
Product Code 49281-400
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		 Adacel Tdap
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		 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 What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		 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 Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.		 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 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.		 49281040020
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 What kind of product is this?
    Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.    		 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)
    Pharmacologic Class(es)
    Sample Package Sample Package?
    This field Indicates whether this package is a sample packaging or not.    		 No
    Marketing Category What is the Marketing Category?
    Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.    		 BLA - A product marketed under an approved Biologic License Application.
    FDA Application Number What is the FDA Application Number?
    This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.    		 BLA125111
    Start Marketing Date What is the Start Marketing Date?
    This is the date that the labeler indicates was the start of its marketing of the drug product.    		 06-10-2005
    Listing Expiration Date What is the Listing Expiration Date?
    This is the date when the listing record will expire if not updated or certified by the product labeler.    		 12-31-2024
    Exclude Flag What is the NDC Exclude Flag?
    This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".     		N
    NDC 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 49281-400-20 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    4928104002090715Tdap vaccine 7 yrs/> im1 EA0.5515

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for Adacel with product NDC 49281-400.

    NDC Package CodePackage Description
    49281-400-055 VIAL in 1 PACKAGE / .5 mL in 1 VIAL (49281-400-58)
    49281-400-1010 VIAL in 1 PACKAGE / .5 mL in 1 VIAL (49281-400-58)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 49281-400-20?

    The NDC Packaged Code 49281-400-20 is assigned to a package of 5 syringe in 1 package / .5 ml in 1 syringe (49281-400-89) 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 49281-400-20?

    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 49281-400-20?

    The 11-digit format is 49281040020. 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 Package Format10-Digit Original Package Code11-Digit Package Format11-Digit Conversion Package Code
    5-3-249281-400-205-4-249281-0400-20