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  5. NDC Package Code: 58160-819-12 Shingrix

NDC Package 58160-819-12 Shingrix

Zoster Vaccine Recombinant,Adjuvanted Kit - 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:
58160-819-12
Package Description:
1 KIT in 1 CARTON * .5 mL in 1 VIAL (58160-828-01) * .5 mL in 1 VIAL (58160-829-01)
Product Code:
58160-819
Proprietary Name:
Shingrix
Non-Proprietary Name:
Zoster Vaccine Recombinant, Adjuvanted
Usage Information:
This vaccine is used by adults 50 years and older to prevent zoster (shingles). Zoster is caused by the same virus that causes chickenpox. After you have been infected with chickenpox (usually in childhood), the virus can live in your body's nerve roots in an inactive form. For reasons that are not fully understood, the virus may become active again. This causes shingles with symptoms of rash, blisters, and pain. This vaccine works by boosting the body's natural defense (immunity) against the zoster virus so that symptoms of shingles do not develop. It should not be used for treating active shingles, nerve pain caused by shingles, or for the prevention of chickenpox. Vaccines may not fully protect everyone who receives them. This vaccine should not be used by children.
11-Digit NDC Billing Format:
58160081912
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
  • RxCUI: 1986825 - varicella zoster virus glycoprotein E vaccine recombinant 0.1 MG/mL Injection
  • RxCUI: 1986825 - 0.5 ML varicella zoster virus glycoprotein E, recombinant 0.1 MG/ML Injection
  • RxCUI: 1986825 - 0.5 ML zoster vaccine, recombinant 0.1 MG/ML
  • RxCUI: 1986830 - SHINGRIX vaccine 0.5 ML Injection
  • RxCUI: 1986830 - 0.5 ML varicella zoster virus glycoprotein E, recombinant 0.1 MG/ML Injection [Shingrix]
    • Product Type:
    Vaccine
    Labeler Name:
    Glaxosmithkline Biologicals Sa
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    BLA125614
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    10-20-2017
    End Marketing Date:
    08-23-2025
    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 58160-819-12?

    The NDC Packaged Code 58160-819-12 is assigned to a package of 1 kit in 1 carton * .5 ml in 1 vial (58160-828-01) * .5 ml in 1 vial (58160-829-01) of Shingrix, a vaccine label labeled by Glaxosmithkline Biologicals Sa. The product's dosage form is kit and is administered via form.

    Is NDC 58160-819 included in the NDC Directory?

    Yes, Shingrix with product code 58160-819 is active and included in the NDC Directory. The product was first marketed by Glaxosmithkline Biologicals Sa on October 20, 2017.

    What is the NDC billing unit for package 58160-819-12?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units.

    What is the 11-digit format for NDC 58160-819-12?

    The 11-digit format is 58160081912. 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
    5-3-258160-819-125-4-258160-0819-12