ENGERIX-B - 58160-820-52 - (Hepatitis B Vaccine (Recombinant))

Alphabetical Index


Drug Information of ENGERIX-B

Product NDC: 58160-820
Proprietary Name: ENGERIX-B
Non Proprietary Name: Hepatitis B Vaccine (Recombinant)
Active Ingredient(s): 10    ug/.5mL & nbsp;   Hepatitis B Vaccine (Recombinant)
Administration Route(s): INTRAMUSCULAR
Dosage Form(s): INJECTION, SUSPENSION
Coding System: National Drug Codes(NDC)

Labeler Information of ENGERIX-B

Product NDC: 58160-820
Labeler Name: GlaxoSmithKline Biologicals SA
Product Type: VACCINE
FDA Application Number: BLA103239
Marketing Category: BLA
Start Marketing Date: 20070425

Package Information of ENGERIX-B

Package NDC: 58160-820-52
Package Description: 10 SYRINGE in 1 CARTON (58160-820-52) > .5 mL in 1 SYRINGE (58160-820-43)

NDC Information of ENGERIX-B

NDC Code 58160-820-52
Proprietary Name ENGERIX-B
Package Description 10 SYRINGE in 1 CARTON (58160-820-52) > .5 mL in 1 SYRINGE (58160-820-43)
Product NDC 58160-820
Product Type Name VACCINE
Non Proprietary Name Hepatitis B Vaccine (Recombinant)
Dosage Form Name INJECTION, SUSPENSION
Route Name INTRAMUSCULAR
Start Marketing Date 20070425
Marketing Category Name BLA
Labeler Name GlaxoSmithKline Biologicals SA
Substance Name HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN
Strength Number 10
Strength Unit ug/.5mL
Pharmaceutical Classes

Complete Information of ENGERIX-B


General Information