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, Suspension
NDC Package 50090-1079-0

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

Package Information

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 adacel® is a vaccine indicated for: - Active booster immunization against tetanus, diphtheria and pertussis. This formulation utilizes a injection, suspension delivery system. Marketed by A-s Medication Solutions, this product is identified by NDC 50090-1079 and is authorized under FDA application BLA125111.

Identification & Billing

NDC Package Code
50090-1079-0
Package Description
10 VIAL in 1 PACKAGE / .5 mL in 1 VIAL (50090-1079-1)
Product Code
50090-1079
11-Digit Billing Format
50090107900
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1300205 - Tdap (generic for Adacel) 0.5 ML Injection
  • RxCUI: 1300205 - 0.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.01 MG/ML / Bordetella pertussis fimbriae 2/3 vaccine, inactivated 0.01 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.006 MG/ML / Bordetella pertussis toxoid vaccine, inactivated 0.005 MG/ML / diphtheria toxoid vaccine, inactivated 4 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Injection
  • RxCUI: 1300205 - Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 5 MCG / Bordetella pertussis fimbriae 2/3 vaccine, inactivated 5 MCG / Bordetella pertussis pertactin vaccine, inactivated 3 MCG / Bordetella pertussis toxoid vaccine, inactivated 2.5 MCG / diphtheria toxoid vaccine 2 UNT / tetanus toxoid vaccine 5 UNT per 0.5 ML Injection
  • RxCUI: 1300205 - Tdap (tetanus toxoid vaccine, inactivated 5 UNT / diphtheria toxoid vaccine, inactivated 2 UNT / acellular pertussis vaccine, inactivated 15.5 MCG) per 0.5 ML Injection
  • RxCUI: 1300205 - tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (generic for Adacel) 0.5 ML Injection

Clinical Specifications

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
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
Adacel® is a vaccine indicated for: - Active booster immunization against tetanus, diphtheria and pertussis. Adacel is approved for use in individuals 10 through 64 years of age.Immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age.

Regulatory & Marketing

Labeler Name
A-s Medication Solutions
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
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50090-1079-0 identifies a specific commercial package of 10 vial in 1 package / .5 ml in 1 vial (50090-1079-1) of 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, a vaccine label labeled by A-s Medication Solutions. 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 A-s Medication Solutions on June 10, 2005. The current certification is valid through December 31, 2026.

How is this A-s Medication Solutions product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50090107900. 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 (5-4-1)
50090-1079-0
11-Digit CMS (5-4-2)
50090-1079-00

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