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  5. NDC Package Code: 58160-811-52 Pediarix

NDC Package 58160-811-52 Pediarix

Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed,Hepatitis B (recombinant) - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

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:
58160-811-52
Package Description:
10 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE (58160-811-43)
Product Code:
58160-811
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)
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).
11-Digit NDC Billing Format:
58160081152
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • 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: 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 - DTaP-HepB-IPV 0.5 ML Prefilled Syringe
  • RxCUI: 829989 - PEDIARIX vaccine 0.5 ML Prefilled Syringe
Product Type:
Vaccine
Labeler Name:
Glaxosmithkline Biologicals Sa
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.
Active Ingredient(s):
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
BLA103907
Marketing Category:
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date:
07-24-2009
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.

Frequently Asked Questions

What is NDC 58160-811-52?

The NDC Packaged Code 58160-811-52 is assigned to a package of 10 syringe in 1 carton / .5 ml in 1 syringe (58160-811-43) of Pediarix, a vaccine label labeled by Glaxosmithkline Biologicals Sa. The product's dosage form is injection, suspension and is administered via intramuscular form.

Is NDC 58160-811 included in the NDC Directory?

Yes, Pediarix with product code 58160-811 is active and included in the NDC Directory. The product was first marketed by Glaxosmithkline Biologicals Sa on July 24, 2009 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 58160-811-52?

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 58160-811-52?

The 11-digit format is 58160081152. 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
5-3-258160-811-525-4-258160-0811-52