Engerix-b
NDC Package 68258-3042-1

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Engerix-b is indicated for immunization against infection caused by all known subtypes of hepatitis B virus. Marketed by Dispensing Solutions Inc., this product is identified by NDC 68258-3042 and is authorized under FDA application BLA103239.

Identification & Billing

NDC Package Code
68258-3042-1
Package Description
1 VIAL in 1 CARTON / 1 mL in 1 VIAL
Product Code
68258-3042
11-Digit Billing Format
68258304201
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]

Clinical Specifications

Proprietary Name
Engerix-b
Dosage Form
-
Usage Information
ENGERIX-B is indicated for immunization against infection caused by all known subtypes of hepatitis B virus. As hepatitis D (caused by the delta virus) does not occur in the absence of hepatitis B infection, it can be expected that hepatitis D will also be prevented by ENGERIX-B vaccination.ENGERIX-B will not prevent hepatitis caused by other agents, such as hepatitis A, C, and E viruses, or other pathogens known to infect the liver.Immunization is recommended in persons of all ages, especially those who are, or will be, at increased risk of exposure to hepatitis B virus,1 for example:Infants, Including Those Born of HBsAg-Positive Mothers (See DOSAGE AND ADMINISTRATION.)Adolescents (See CLINICAL PHARMACOLOGY.)Healthcare Personnel: Dentists and oral surgeons.Dental, medical, and nursing students. Physicians, surgeons, and podiatrists. Nurses. Paramedical and ambulance personnel and custodial staff who may be exposed to the virus via blood or other patient specimens. Dental hygienists and dental nurses. Laboratory and blood bank personnel handling blood, blood products, and other patient specimens. Hospital cleaning staff who handle waste.Selected Patients and Patient Contacts: Patients and staff in hemodialysis units and hematology/oncology units. Patients requiring frequent and/or large volume blood transfusions or clotting factor concentrates (e.g., persons with hemophilia, thalassemia, sickle cell anemia, cirrhosis). Clients (residents) and staff of institutions for the mentally handicapped. Classroom contacts of deinstitutionalized mentally handicapped persons who have persistent hepatitis B surface antigenemia and who show aggressive behavior. Household and other intimate contacts of persons with persistent hepatitis B surface antigenemia.Subpopulations With a Known High Incidence of the Disease, such as: Alaskan Eskimos. Pacific Islanders. Indochinese immigrants. Haitian immigrants. Refugees from other HBV-endemic areas. All infants of women born in areas where the infection is highly endemic.Individuals With Chronic Hepatitis C: Risk factors for hepatitis C are similar to those for hepatitis B. Consequently, immunization with hepatitis B vaccine is recommended for individuals with chronic hepatitis C.Persons Who May Be Exposed to the Hepatitis B Virus by Travel to High-Risk Areas (See ACIP Guidelines, 1990.)Military Personnel Identified as Being at Increased RiskMorticians and EmbalmersPersons at Increased Risk of the Disease Due to Their Sexual Practices,1,16 such as: Persons with more than 1 sexual partner in a 6-month period. Persons who have contracted a sexually transmitted disease. Homosexually active males. Female prostitutes.PrisonersUsers of Illicit Injectable DrugsOthers: Police and fire department personnel who render first aid or medical assistance, and any others who, through their work or personal life-style, may be exposed to the hepatitis B virus. Adoptees from countries of high HBV endemicity.

Regulatory & Marketing

Labeler Name
Dispensing Solutions Inc.
FDA Application #
BLA103239
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-28-2009
Listing Expiration
12-31-2017
Exclude Flag
I
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 68258-3042-1 identifies a specific commercial package of 1 vial in 1 carton / 1 ml in 1 vial of Engerix-b, labeled by Dispensing Solutions Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Dispensing Solutions Inc. on May 28, 2009. The current certification is valid through December 31, 2017.

How is this Dispensing Solutions Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68258304201. 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 (5-4-1)
68258-3042-1
11-Digit CMS (5-4-2)
68258-3042-01

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