Pediarix Injection, Suspension
NDC Package 50090-7541-0

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

Package Information

Pediarix (diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis b (recombinant) and inactivated poliovirus vaccine combined) injection is a medication a combination of vaccines. This formulation utilizes a injection, suspension delivery system. Marketed by A-s Medication Solutions, this product is identified by NDC 50090-7541 and is authorized under FDA application BLA103907.

Identification & Billing

NDC Package Code
50090-7541-0
Package Description
10 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE (50090-7541-1)
Product Code
50090-7541
11-Digit Billing Format
50090754100
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 829987 - DTaP-HepB-IPV 0.5 ML Prefilled Syringe
  • RxCUI: 829987 - 0.5 ML acellular pertussis vaccine, inactivated 0.116 MG/ML / diphtheria toxoid vaccine, inactivated 50 UNT/ML / hepatitis B surface antigen vaccine 0.02 MG/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: 829987 - acellular pertussis vaccine 0.058 MG / diphtheria toxoid vaccine 25 UNT / hepatitis B surface antigen vaccine 0.01 MG / 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: 829987 - diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B and inactivated poliovirus vaccine (DTaP-HepB-IPV) 0.5 ML Prefilled Syringe
  • RxCUI: 829989 - PEDIARIX vaccine 0.5 ML Prefilled Syringe

Clinical Specifications

Proprietary Name
Pediarix
Non-Proprietary Name
Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed, Hepatitis B (recombinant) And Inactivated Poliovirus Vaccine Combined
Substance Name
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); Hepatitis B Virus Subtype Adw2 Hbsag Surface Protein Antigen; Poliovirus Type 1 Antigen (formaldehyde Inactivated); Poliovirus Type 2 Antigen (formaldehyde Inactivated); Poliovirus Type 3 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 medication is a combination of vaccines. It is given to children between the ages of 6 weeks and 7 years old to prevent certain serious diseases: diphtheria, tetanus (lockjaw), pertussis (whooping cough), hepatitis B, and polio. 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).

Regulatory & Marketing

Labeler Name
A-s Medication Solutions
Product Type
Vaccine
FDA Application #
BLA103907
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-24-2009
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 50090-7541-0 identifies a specific commercial package of 10 syringe in 1 carton / .5 ml in 1 syringe (50090-7541-1) of Pediarix, 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 pertactin antigen (formaldehyde inactivated); bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated); clostridium tetani toxoid antigen (formaldehyde inactivated); corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated); hepatitis b virus subtype adw2 hbsag surface protein antigen; poliovirus type 1 antigen (formaldehyde inactivated); poliovirus type 2 antigen (formaldehyde inactivated); poliovirus type 3 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 July 24, 2009. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is a combination of vaccines. It is given to children between the ages of 6 weeks and 7 years old to prevent certain serious diseases: diphtheria, tetanus (lockjaw), pertussis (whooping cough), hepatitis B, and polio. 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).

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: 50090754100. 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)
50090-7541-0
11-Digit CMS (5-4-2)
50090-7541-00

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