1. Home
  2. Labeler Index
  3. Glaxosmithkline Biologicals Sa
  4. 58160-815
  5. NDC Package Code: 58160-815-52 Twinrix

NDC Package 58160-815-52 Twinrix

Hepatitis A And Hepatitis B (recombinant) Vaccine Injection, Suspension Intramuscular - 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:
58160-815-52
Package Description:
10 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE (58160-815-43)
Product Code:
58160-815
Proprietary Name:
Twinrix
Non-Proprietary Name:
Hepatitis A And Hepatitis B (recombinant) Vaccine
Substance Name:
Hepatitis A Virus Strain Hm175 Antigen (formaldehyde Inactivated); Hepatitis B Virus Subtype Adw2 Hbsag Surface Protein Antigen
Usage Information:
This combination vaccine is used to help prevent infection from the hepatitis A and B viruses. Hepatitis A infection can be mild with no symptoms or a severe illness that can rarely cause liver failure and death. Hepatitis B infection can cause serious problems including liver failure, persistent hepatitis B infection, cirrhosis, and liver cancer. Preventing infection with these viruses can prevent these problems. Hepatitis A/hepatitis B combination vaccine is made from whole, killed hepatitis A virus and a genetically engineered (man-made in the laboratory) piece of hepatitis B virus. It does not contain live virus, so you can not get hepatitis from the vaccine. This vaccine works by helping the body produce immunity (through antibody production) that will prevent you from getting infection from hepatitis A and hepatitis B. This combination vaccine does not protect you from other virus infections (such as HIV virus which causes AIDS, hepatitis C/ hepatitis E, HPV virus which causes genital warts and other problems). The vaccine is recommended for people at an increased risk of getting these infections. Those at an increased risk include health care personnel, laboratory workers who handle blood and patient specimens, police, fire and emergency medical personnel who give first aid treatment, hemophiliacs, dialysis patients, people who live with or spend much time with people with persistent hepatitis B or active hepatitis A infections, people with multiple sex partners, men who have sex with men, sex workers, injection drug abusers, and people traveling to high-risk areas.
11-Digit NDC Billing Format:
58160081552
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 803369 - hepatitis A & hepatitis B (recombinant) vaccine (HepA-HepB) 1 ML Prefilled Syringe
  • RxCUI: 803369 - 1 ML hepatitis A vaccine (inactivated) strain HM175 720 UNT/ML / hepatitis B surface antigen vaccine 0.02 MG/ML Prefilled Syringe
  • RxCUI: 803369 - hepatitis A vaccine (inactivated) strain HM175 720 UNT / hepatitis B surface antigen vaccine 0.02 MG per 1 ML Prefilled Syringe
  • RxCUI: 803369 - hepatitis A vaccine (inactivated) strain HM175 720 UNT / hepatitis B surface antigen vaccine 20 MCG per 1 ML Prefilled Syringe
  • RxCUI: 803371 - TWINRIX vaccine 1 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):
  • HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) 720 [iU]/mL
  • HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN 20 ug/mL
    • Pharmacologic Class(es):
  • Actively Acquired Immunity - [PE] (Physiologic Effect)
  • Hepatitis A Vaccines - [CS]
  • Inactivated Hepatitis A Virus Vaccine - [EPC] (Established Pharmacologic Class)
  • Vaccines, Inactivated - [CS]
    • Sample Package:
    No
    FDA Application Number:
    BLA103850
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    06-07-2007
    Listing Expiration Date:
    12-31-2024
    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 58160-815-52?

    The NDC Packaged Code 58160-815-52 is assigned to a package of 10 syringe in 1 carton / 1 ml in 1 syringe (58160-815-43) of Twinrix, a vaccine label labeled by Glaxosmithkline Biologicals Sa. The product's dosage form is injection, suspension and is administered via intramuscular form.

    Is NDC 58160-815 included in the NDC Directory?

    Yes, Twinrix with product code 58160-815 is active and included in the NDC Directory. The product was first marketed by Glaxosmithkline Biologicals Sa on June 07, 2007 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 58160-815-52?

    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 58160-815-52?

    The 11-digit format is 58160081552. 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
    5-3-258160-815-525-4-258160-0815-52