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NDC 49281-215 Tenivac

Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated) And Corynebacterium - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 49281-215?
  5. Tenivac Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

NDC Product Code:
49281-215
Proprietary Name:
Tenivac
Non-Proprietary Name: [1]
Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated) And Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated)
Substance Name: [2]
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:
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]
    Sanofi Pasteur Inc.
    Labeler Code:
    49281
    Product Label ID:
    1a87f53c-0c8a-4c66-9048-2a0cf60a6a5c
    FDA Application Number: [6]
    BLA103171
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    12-08-2010
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - WHITE CLOUDY)

    Code Structure Chart

    Product Details

    What is NDC 49281-215?

    The NDC code 49281-215 is assigned by the FDA to the product Tenivac which is a vaccine label product labeled by Sanofi Pasteur Inc.. The generic name of Tenivac is clostridium tetani toxoid antigen (formaldehyde inactivated) and corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated). The product's dosage form is injection, suspension and is administered via intramuscular form. The product is distributed in 2 packages with assigned NDC codes 49281-215-10 10 vial, single-dose in 1 package / .5 ml in 1 vial, single-dose (49281-215-58), 49281-215-15 10 syringe in 1 package / .5 ml in 1 syringe (49281-215-88). 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 Tenivac?

    This vaccine is used to help prevent problems that may occur with 2 bacterial infections in children and adults (tetanus and diphtheria). Tetanus (lockjaw) and diphtheria can cause serious, sometimes fatal problems (heart problems, nerve problems, muscle paralysis). Vaccination is the best way to protect (provide immunity) against these life-threatening diseases. Vaccines work by getting the body to make its own protection (antibodies). This vaccine is recommended for all people 7 years and older. Diphtheria and tetanus toxoids combined (adult) injection should not be used in anyone younger than 7 years because they may not be fully protected by this vaccine. A vaccine for children younger than 7 years is available. Consult your child's health care professional for more information.

    What are Tenivac 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 Tenivac 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)

    Which are Tenivac 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 Tenivac?

    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: 1190916 - TENIVAC vaccine 0.5 ML Injection
    • RxCUI: 1190916 - 0.5 ML diphtheria toxoid vaccine, inactivated 4 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Injection [Tenivac]
    • RxCUI: 1190916 - Tenivac (Diphtheria Toxoid Vaccine 2 UNT / Tetanus Toxoid Vaccine 5 UNT) per 0.5 ML Injection
    • RxCUI: 1190919 - TENIVAC vaccine 0.5 ML Prefilled Syringe
    • RxCUI: 1190919 - 0.5 ML diphtheria toxoid vaccine, inactivated 4 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Prefilled Syringe [Tenivac]

    Which are the Pharmacologic Classes for Tenivac?

    * Please review the disclaimer below.

    Patient Education

    Tetanus, Diphtheria (Td) Vaccine


    Why get vaccinated? Td vaccine can prevent tetanus and diphtheria. Tetanus enters the body through cuts or wounds. Diphtheria spreads from person to person. 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.
    [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".