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NDC 58160-842 Boostrix

Tetanus Toxoid,Reduced Diphtheria Toxoid And Acellular Pertussis Vaccine,Adsorbed - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 58160-842?
  4. Boostrix Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

NDC Product Code:
58160-842
Proprietary Name:
Boostrix
Non-Proprietary Name: [1]
Tetanus Toxoid, Reduced Diphtheria Toxoid And Acellular Pertussis Vaccine, Adsorbed
Substance Name: [2]
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)
NDC Directory Status:
Vaccine
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route(s): [4]
  • Intramuscular - Administration within a muscle.
    • Labeler Name: [5]
    Glaxosmithkline Biologicals Sa
    Labeler Code:
    58160
    Product Label ID:
    cd98bff9-4602-4268-d68d-029a14a5513b
    FDA Application Number: [6]
    BLA125106
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    07-24-2009
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 58160-842?

    The NDC code 58160-842 is assigned by the FDA to the product Boostrix which is a vaccine label product labeled by Glaxosmithkline Biologicals Sa. The generic name of Boostrix is tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed. The product's dosage form is suspension and is administered via intramuscular form. The product is distributed in 2 packages with assigned NDC codes 58160-842-11 10 vial in 1 carton / .5 ml in 1 vial (58160-842-01), 58160-842-52 10 syringe in 1 carton / .5 ml in 1 syringe (58160-842-43). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Boostrix?

    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.

    What are Boostrix Active Ingredients?

    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.

    Which are Boostrix UNII Codes?

    The UNII codes for the active ingredients in this product are:

    • CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: K3W1N8YP13)
    • CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: K3W1N8YP13) (Active Moiety)
    • CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: IRH51QN26H)
    • CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: IRH51QN26H) (Active Moiety)
    • BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) (UNII: QSN5XO8ZSU)
    • BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) (UNII: QSN5XO8ZSU) (Active Moiety)
    • BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 8C367IY4EY)
    • BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 8C367IY4EY) (Active Moiety)
    • BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: I05O535NV6)
    • BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: I05O535NV6) (Active Moiety)

    Which are Boostrix Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Boostrix?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • 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

    * Please review the disclaimer below.

    Patient Education

    Diphtheria, Tetanus, and Pertussis (DTaP) Vaccine


    Why get vaccinated? DTaP vaccine can prevent diphtheria, tetanus, and pertussis. Diphtheria and pertussis spread from person to person. Tetanus enters the body through cuts or wounds. DIPHTHERIA (D) can lead to difficulty breathing, heart failure, paralysis, and death. TETANUS (T) causes painful tightening of the muscles. Tetanus can lead to serious health problems, including being unable to open the mouth, having trouble swallowing and breathing, or death. PERTUSSIS (aP), also known as "whooping cough," can cause uncontrollable, violent coughing that makes it hard to breathe, eat, or drink. Pertussis can be extremely serious especially in babies and young children, causing pneumonia, convulsions, brain damage, or death. In teens and adults, it can cause weight loss, loss of bladder control, passing out, and rib fractures from severe coughing.
    [Learn More]


    Tetanus, Diphtheria, Pertussis (Tdap) Vaccine


    Why get vaccinated? Tdap vaccine can prevent tetanus, diphtheria, and pertussis. Diphtheria and pertussis spread from person to person. Tetanus enters the body through cuts or wounds. TETANUS (T) causes painful stiffening of the muscles. Tetanus can lead to serious health problems, including being unable to open the mouth, having trouble swallowing and breathing, or death. DIPHTHERIA (D) can lead to difficulty breathing, heart failure, paralysis, or death. PERTUSSIS (aP) , also known as "whooping cough," can cause uncontrollable, violent coughing that makes it hard to breathe, eat, or drink. Pertussis can be extremely serious especially in babies and young children, causing pneumonia, convulsions, brain damage, or death. In teens and adults, it can cause weight loss, loss of bladder control, passing out, and rib fractures from severe coughing.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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] 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".