ENGERIX-B - 58160-821-11 - (Hepatitis B Vaccine (Recombinant))

Alphabetical Index


Drug Information of ENGERIX-B

Product NDC: 58160-821
Proprietary Name: ENGERIX-B
Non Proprietary Name: Hepatitis B Vaccine (Recombinant)
Active Ingredient(s): 20    ug/mL & 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: 58160-821
Labeler Name: GlaxoSmithKline Biologicals SA
Product Type: VACCINE
FDA Application Number: BLA103239
Marketing Category: BLA
Start Marketing Date: 20070328

Package Information of ENGERIX-B

Package NDC: 58160-821-11
Package Description: 10 VIAL in 1 CARTON (58160-821-11) > 1 mL in 1 VIAL (58160-821-01)

NDC Information of ENGERIX-B

NDC Code 58160-821-11
Proprietary Name ENGERIX-B
Package Description 10 VIAL in 1 CARTON (58160-821-11) > 1 mL in 1 VIAL (58160-821-01)
Product NDC 58160-821
Product Type Name VACCINE
Non Proprietary Name Hepatitis B Vaccine (Recombinant)
Dosage Form Name INJECTION, SUSPENSION
Route Name INTRAMUSCULAR
Start Marketing Date 20070328
Marketing Category Name BLA
Labeler Name GlaxoSmithKline Biologicals SA
Substance Name HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN
Strength Number 20
Strength Unit ug/mL
Pharmaceutical Classes

Complete Information of ENGERIX-B


General Information