NDC Package 58160-821-11 Engerix-b

Hepatitis B Vaccine (recombinant) Injection, Suspension Intramuscular - 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:
58160-821-11
Package Description:
10 VIAL in 1 CARTON / 1 mL in 1 VIAL (58160-821-01)
Product Code:
Proprietary Name:
Engerix-b
Non-Proprietary Name:
Hepatitis B Vaccine (recombinant)
Substance Name:
Hepatitis B Virus Subtype Adw2 Hbsag Surface Protein Antigen
Usage Information:
ENGERIX-B® is indicated for immunization against infection caused by all known subtypes of hepatitis B virus.
11-Digit NDC Billing Format:
58160082111
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1658156 - hepatitis B vaccine (recombinant) adult 20 MCG in 1 ML Injection
  • RxCUI: 1658156 - 1 ML hepatitis B surface antigen vaccine 0.02 MG/ML Injection
  • RxCUI: 1658156 - hepatitis B surface antigen vaccine 20 MCG per 1 ML Injection
  • RxCUI: 1658157 - ENGERIX-B adult 20 MCG in 1 ML Injection
  • RxCUI: 1658157 - 1 ML hepatitis B surface antigen vaccine 0.02 MG/ML Injection [Engerix-B]
  • 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.
  • Sample Package:
    No
    FDA Application Number:
    BLA103239
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    03-28-2007
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 58160-821-11 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    5816008211190740HEPB VACC 3 DOSE IMMUNSUP IM40 MCG1100.55
    5816008211190746HEPB VACCINE 3 DOSE ADULT IM1 DOSE110110
    5816008211190747HEPB VACC 4 DOSE IMMUNSUP IM40 MCG1100.55

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    58160-821-341 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE (58160-821-05)
    58160-821-5210 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE (58160-821-43)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 58160-821-11?

    The NDC Packaged Code 58160-821-11 is assigned to a package of 10 vial in 1 carton / 1 ml in 1 vial (58160-821-01) of Engerix-b, a vaccine label labeled by Glaxosmithkline Biologicals Sa. The product's dosage form is injection, suspension and is administered via intramuscular form.

    Is NDC 58160-821 included in the NDC Directory?

    Yes, Engerix-b with product code 58160-821 is active and included in the NDC Directory. The product was first marketed by Glaxosmithkline Biologicals Sa on March 28, 2007 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 58160-821-11?

    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 58160-821-11?

    The 11-digit format is 58160082111. 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
    5-3-258160-821-115-4-258160-0821-11