NDC 58160-842-11 Boostrix
Tetanus Toxoid, Reduced Diphtheria Toxoid And Acellular Pertussis Vaccine, Adsorbed 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 58160-842-11
Package Description 10 VIAL in 1 CARTON / .5 mL in 1 VIAL (58160-842-01)
Product Code 58160-842
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.		 Boostrix
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.		 Tetanus Toxoid, Reduced Diphtheria Toxoid And Acellular Pertussis Vaccine, Adsorbed
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 Pertactin Antigen (formaldehyde Inactivated); Bordetella Pertussis Toxoid Antigen (formaldehyde, 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.		 BOOSTRIX® is indicated for active booster immunization against tetanus, diphtheria, and pertussis. BOOSTRIX is approved for use as a single dose in individuals 10 years of age and older.
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.		 58160084211
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk
  • RxCUI: 1300368 - tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Tdap generic for Boostrix) 0.5 ML Prefilled Syringe
  • RxCUI: 1300368 - 0.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.016 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.005 MG/ML / Bordetella pertussis toxoid vaccine, inactivated 0.016 MG/ML / diphtheria toxoid vaccine, inactivated 5 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Prefilled Syringe
  • RxCUI: 1300368 - Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 8 MCG / Bordetella pertussis pertactin vaccine, inactivated 2.5 MCG / Bordetella pertussis toxoid vaccine, inactivated 8 MCG / diphtheria toxoid vaccine, inactivated 2.5 UNT / tetanus toxoid vaccine, inactivated 5 UNT per 0.5 ML Prefilled Syringe
  • RxCUI: 1300368 - Tdap (tetanus toxoid vaccine, inactivated 5 UNT / diphtheria toxoid vaccine, inactivated 2.5 UNT / acellular pertussis vaccine, inactivated 18.5 MCG) per 0.5 ML Prefilled Syringe
  • RxCUI: 1300370 - BOOSTRIX vaccine 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 Glaxosmithkline Biologicals Sa
    Dosage Form Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    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.    		 BLA125106
    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.    		 07-24-2009
    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 58160-842-11 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    5816008421190715Tdap vaccine 7 yrs/> im0.5 ML0.510110

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for Boostrix with product NDC 58160-842.

    NDC Package CodePackage Description
    58160-842-5210 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE (58160-842-43)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 58160-842-11?

    The NDC Packaged Code 58160-842-11 is assigned to a package of 10 vial in 1 carton / .5 ml in 1 vial (58160-842-01) of Boostrix, a vaccine label labeled by Glaxosmithkline Biologicals Sa. The product's dosage form is suspension and is administered via intramuscular form.

    Is NDC 58160-842 included in the NDC Directory?

    Yes, Boostrix with product code 58160-842 is active and included in the NDC Directory. The product was first marketed by Glaxosmithkline Biologicals Sa on July 24, 2009 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 58160-842-11?

    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 58160-842-11?

    The 11-digit format is 58160084211. 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
    5-3-258160-842-115-4-258160-0842-11