This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
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:
68258-3042-1
Package Description:
1 VIAL in 1 CARTON / 1 mL in 1 VIAL
Proprietary Name:
Engerix-b
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.
11-Digit NDC Billing Format:
68258304201
NDC to RxNorm Crosswalk:
RxCUI: 1658156 - hepatitis B vaccine (recombinant) adult 20 MCG in 1 ML InjectionRxCUI: 1658156 - 1 ML hepatitis B surface antigen vaccine 0.02 MG/ML InjectionRxCUI: 1658156 - hepatitis B surface antigen vaccine 20 MCG per 1 ML InjectionRxCUI: 1658157 - ENGERIX-B adult 20 MCG in 1 ML InjectionRxCUI: 1658157 - 1 ML hepatitis B surface antigen vaccine 0.02 MG/ML Injection [Engerix-B] Labeler Name:
Dispensing Solutions Inc.
Start Marketing Date:
05-28-2009
Listing Expiration Date:
12-31-2017
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.
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