NDC Package 58160-810-52 Infanrix

Diphtheria And Tetanus Toxoids And Acellular Pertussis Vaccine Adsorbed Suspension - View Billable Units, 11-Digit Format, RxNorm

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:
58160-810-52
Package Description:
10 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE (58160-810-43)
Product Code:
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)
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).
11-Digit NDC Billing Format:
58160081052
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1300382 - diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (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 - 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
  • RxCUI: 1300384 - INFANRIX vaccine 0.5 ML Prefilled Syringe
  • Product Type:
    Vaccine
    Labeler Name:
    Glaxosmithkline Biologicals Sa
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    Administration Route(s):
  • Intramuscular - Administration within a muscle.
  • Sample Package:
    No
    FDA Application Number:
    BLA103647
    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 58160-810-52?

    The NDC Packaged Code 58160-810-52 is assigned to a 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. The product's dosage form is suspension and is administered via intramuscular form.

    Is NDC 58160-810 included in the NDC Directory?

    Yes, Infanrix with product code 58160-810 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 58160-810-52?

    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 58160-810-52?

    The 11-digit format is 58160081052. 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
    5-3-258160-810-525-4-258160-0810-52