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NDC 58160-812 Kinrix

Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 58160-812?
  4. Kinrix 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:
58160-812
Proprietary Name:
Kinrix
Non-Proprietary Name: [1]
Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus Vaccine
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); Poliovirus Type 1 Antigen (formaldehyde Inactivated); Poliovirus Type 2 Antigen (formaldehyde Inactivated); Poliovirus Type 3 Antigen (formaldehyde Inactivated)
NDC Directory Status:
Vaccine
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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): [4]
  • Intramuscular - Administration within a muscle.
    • Labeler Name: [5]
    Glaxosmithkline Biologicals Sa
    Labeler Code:
    58160
    Product Label ID:
    6b5f89e9-1292-4f13-5590-44c874bf299c
    FDA Application Number: [6]
    BLA125260
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    07-09-2008
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 58160-812?

    The NDC code 58160-812 is assigned by the FDA to the product Kinrix which is a vaccine label product labeled by Glaxosmithkline Biologicals Sa. The generic name of Kinrix is diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine. The product's dosage form is injection, suspension and is administered via intramuscular form. The product is distributed in a single package with assigned NDC code 58160-812-52 10 syringe in 1 carton / .5 ml in 1 syringe (58160-812-43). 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 Kinrix?

    This medication is a combination of vaccines against diphtheria, tetanus (lockjaw), pertussis (whooping cough), and polio. Vaccination is the best way to protect against these life-threatening infections. Vaccines work by causing the body to produce its own protection (antibodies). Vaccines may not fully protect everyone who receives them.

    What are Kinrix 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 Kinrix UNII Codes?

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

    • CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: IRH51QN26H)
    • CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: IRH51QN26H) (Active Moiety)
    • CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: K3W1N8YP13)
    • CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: K3W1N8YP13) (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)
    • BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) (UNII: QSN5XO8ZSU)
    • BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) (UNII: QSN5XO8ZSU) (Active Moiety)
    • POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 0LVY784C09)
    • POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 0LVY784C09) (Active Moiety)
    • POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 23JE9KDF4R)
    • POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 23JE9KDF4R) (Active Moiety)
    • POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 459ROM8M9M)
    • POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 459ROM8M9M) (Active Moiety)

    Which are Kinrix 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 Kinrix?

    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: 830555 - diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine (DTaP-IPV generic for Kinrix) 0.5 ML Prefilled Syringe
    • RxCUI: 830555 - 0.5 ML acellular pertussis vaccine, inactivated 0.116 MG/ML / diphtheria toxoid vaccine, inactivated 50 UNT/ML / poliovirus vaccine inactivated, type 1 (Mahoney) 80 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 16 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 64 UNT/ML / tetanus toxoid vaccine, inactivated 20 UNT/ML Prefilled Syringe
    • RxCUI: 830555 - acellular pertussis vaccine 0.058 MG / diphtheria toxoid vaccine 25 UNT / poliovirus vaccine inactivated, type 1 (Mahoney) 40 UNT / poliovirus vaccine inactivated, type 2 (MEF-1) 8 UNT / poliovirus vaccine inactivated, type 3 (Saukett) 32 UNT / tetanus toxoid vaccine 10 UNT per 0.5 ML Prefilled Syringe
    • RxCUI: 830555 - DTaP-IPV 0.5 ML Prefilled Syringe
    • RxCUI: 830557 - KINRIX vaccine 0.5 ML Prefilled Syringe

    Which are the Pharmacologic Classes for Kinrix?

    * Please review the disclaimer below.

    Patient Education

    Polio Vaccine


    Why get vaccinated? Polio vaccine can prevent polio. Polio (or poliomyelitis) is a disabling and lifethreatening disease caused by poliovirus, which can infect a person's spinal cord, leading to paralysis. Most people infected with polio have no symptoms, and many recover without complications. Some people will experience sore throat, fever, tiredness, nausea, headache, or stomach pain. A smaller group of people will develop more serious symptoms that affect the brain and spinal cord: Paresthesia (feeling of pins and needles in the legs), Meningitis (infection of the covering of the spinal cord and/or brain), or Paralysis (can't move parts of the body) or weakness in the arms, legs, or both. Paralysis is the most severe symptom associated with polio because it can lead to permanent disability and death. Improvements in limb paralysis can occur, but in some people new muscle pain and weakness may develop 15 to 40 years later. This is called "post-polio syndrome. Polio has been eliminated from the United States, but it still occurs in other parts of the world. The best way to protect yourself and keep the United States polio-free is to maintain high immunity (protection) in the population against polio through vaccination.
    [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".