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) |
Product NDC: | 58160-820 |
Labeler Name: | GlaxoSmithKline Biologicals SA |
Product Type: | VACCINE |
FDA Application Number: | BLA103239 |
Marketing Category: | BLA |
Start Marketing Date: | 20070425 |
Package NDC: | 58160-820-11 |
Package Description: | 10 VIAL in 1 CARTON (58160-820-11) > .5 mL in 1 VIAL (58160-820-01) |
NDC Code | 58160-820-11 |
Proprietary Name | ENGERIX-B |
Package Description | 10 VIAL in 1 CARTON (58160-820-11) > .5 mL in 1 VIAL (58160-820-01) |
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 |