NDC Package 49281-215-10 Tenivac

Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated) And Corynebacterium - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find 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:
49281-215-10
Package Description:
10 VIAL, SINGLE-DOSE in 1 PACKAGE / .5 mL in 1 VIAL, SINGLE-DOSE (49281-215-58)
Product Code:
Proprietary Name:
Tenivac
Non-Proprietary Name:
Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated) And Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated)
Substance Name:
Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated); Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated)
Usage Information:
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.
11-Digit NDC Billing Format:
49281021510
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • 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]
  • Product Type:
    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.
  • Sample Package:
    No
    FDA Application Number:
    BLA103171
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    12-08-2010
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    49281-215-1510 SYRINGE in 1 PACKAGE / .5 mL in 1 SYRINGE (49281-215-88)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 49281-215-10?

    The NDC Packaged Code 49281-215-10 is assigned to a package of 10 vial, single-dose in 1 package / .5 ml in 1 vial, single-dose (49281-215-58) of Tenivac, a vaccine label labeled by Sanofi Pasteur Inc.. The product's dosage form is injection, suspension and is administered via intramuscular form.

    Is NDC 49281-215 included in the NDC Directory?

    Yes, Tenivac with product code 49281-215 is active and included in the NDC Directory. The product was first marketed by Sanofi Pasteur Inc. on December 08, 2010 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 49281-215-10?

    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 49281-215-10?

    The 11-digit format is 49281021510. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-249281-215-105-4-249281-0215-10