Adacel Injection, Suspension
NDC Package 49281-400-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Adacel (clostridium tetani toxoid antigen (formaldehyde inactivated), corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated), bordetella pertussis pertactin antigen, and bordetella pertussis fimbriae 2/3 antigen) injection is this vaccine is used to keep up protection (immunity) against diphtheria, tetanus (lockjaw) and pertussis (whooping cough) in children and adults who have been vaccinated for these diseases in the past. This formulation utilizes a injection, suspension delivery system. Marketed by Sanofi Vaccines Us Inc., this product is identified by NDC 49281-400 and is authorized under FDA application BLA125111.

Identification & Billing

NDC Package Code
49281-400-10
Package Description
10 VIAL in 1 PACKAGE / .5 mL in 1 VIAL (49281-400-58)
Product Code
49281-400
11-Digit Billing Format
49281040010
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Adacel Tdap
Non-Proprietary Name
Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated), Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated), Bordetella Pertussis Toxoid Antigen (glutaraldehyde Inactivated), Bordetella Pertussis Filamentous Hemagglutinin Antigen (formaldehyde Inactivated), Bordetella Pertussis Pertactin Antigen, And Bordetella Pertussis Fimbriae 2/3 Antigen
Substance Name
Bordetella Pertussis Filamentous Hemagglutinin Antigen (formaldehyde Inactivated); Bordetella Pertussis Fimbriae 2/3 Antigen; Bordetella Pertussis Pertactin Antigen; Bordetella Pertussis Toxoid Antigen (glutaraldehyde Inactivated); Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated); Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated)
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
Intramuscular - Administration within a muscle.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This vaccine is used to keep up protection (immunity) against diphtheria, tetanus (lockjaw) and pertussis (whooping cough) in children and adults who have been vaccinated for these diseases in the past. Vaccination is the best way to protect against these life-threatening diseases. Vaccines work by causing the body to produce its own protection (antibodies). Booster doses are needed to keep up immunity because antibody levels may become too low over time to provide the needed protection.

Regulatory & Marketing

Labeler Name
Sanofi Vaccines Us Inc.
Product Type
Vaccine
FDA Application #
BLA125111
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-10-2005
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (49281-400). Click a package code to view its specific billing and regulatory data.

49281-400-20
5 SYRINGE in 1 PACKAGE / .5 mL in 1 SYRINGE (49281-400-89)

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 49281-400-10 identifies a specific commercial package of 10 vial in 1 package / .5 ml in 1 vial (49281-400-58) of Adacel Tdap, a vaccine label labeled by Sanofi Vaccines Us Inc.. This injection, suspension is formulated for intramuscular use and contains bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated); bordetella pertussis fimbriae 2/3 antigen; bordetella pertussis pertactin antigen; bordetella pertussis toxoid antigen (glutaraldehyde inactivated); clostridium tetani toxoid antigen (formaldehyde inactivated); corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Sanofi Vaccines Us Inc. on June 10, 2005. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This vaccine is used to keep up protection (immunity) against diphtheria, tetanus (lockjaw) and pertussis (whooping cough) in children and adults who have been vaccinated for these diseases in the past. Vaccination is the best way to protect against these life-threatening diseases. Vaccines work by causing the body to produce its own protection (antibodies). Booster doses are needed to keep up immunity because antibody levels may become too low over time to provide the needed protection.

How is this Sanofi Vaccines Us Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49281040010. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
49281-400-10
11-Digit CMS (5-4-2)
49281-0400-10

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.