Infanrix Suspension
NDC Package 58160-810-52

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

Package Information

Infanrix (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) suspension is iNFANRIX® is indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children 6 weeks to 7 years of age (prior to seventh birthday). This formulation utilizes a suspension delivery system. Marketed by Glaxosmithkline Biologicals Sa, this product is identified by NDC 58160-810 and is authorized under FDA application BLA103647.

Identification & Billing

NDC Package Code
58160-810-52
Package Description
10 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE (58160-810-43)
Product Code
58160-810
11-Digit Billing Format
58160081052
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1300382 - DTaP (generic for Infanrix) 0.5 ML Prefilled Syringe
  • RxCUI: 1300382 - 0.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.05 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.016 MG/ML / Bordetella pertussis toxoid vaccine, inactivated 0.05 MG/ML / diphtheria toxoid vaccine, inactivated 50 UNT/ML / tetanus toxoid vaccine, inactivated 20 UNT/ML Prefilled Syringe
  • RxCUI: 1300382 - Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 25 MCG / Bordetella pertussis pertactin vaccine, inactivated 8 MCG / Bordetella pertussis toxoid vaccine, inactivated 25 MCG / diphtheria toxoid vaccine, inactivated 25 UNT / tetanus toxoid vaccine, inactivated 10 UNT per 0.5 ML Prefilled Syringe
  • RxCUI: 1300382 - diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP generic for Infanrix) 0.5 ML Prefilled Syringe
  • RxCUI: 1300382 - DTaP (diphtheria toxoid vaccine, inactivated 25 UNT / tetanus toxoid vaccine, inactivated 10 UNT / acellular pertussis vaccine, inactivated 25 UNT) per 0.5 ML Prefilled Syringe

Clinical Specifications

Proprietary Name
Infanrix
Non-Proprietary Name
Diphtheria And Tetanus Toxoids And Acellular Pertussis Vaccine Adsorbed
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)
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
Pharmacologic Class
Usage Information
INFANRIX® is indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children 6 weeks to 7 years of age (prior to seventh birthday).

Regulatory & Marketing

Labeler Name
Glaxosmithkline Biologicals Sa
Product Type
Vaccine
FDA Application #
BLA103647
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-24-2009
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 58160-810-52 identifies a specific commercial package of 10 syringe in 1 carton / .5 ml in 1 syringe (58160-810-43) of Infanrix, a vaccine label labeled by Glaxosmithkline Biologicals Sa. This 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) 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 Glaxosmithkline Biologicals Sa on July 24, 2009. The current certification is valid through December 31, 2027.

How is this Glaxosmithkline Biologicals Sa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58160081052. 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)
58160-810-52
11-Digit CMS (5-4-2)
58160-0810-52

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