| 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) |
| Product NDC: | 58160-821 |
| Labeler Name: | GlaxoSmithKline Biologicals SA |
| Product Type: | VACCINE |
| FDA Application Number: | BLA103239 |
| Marketing Category: | BLA |
| Start Marketing Date: | 20070328 |
| Package NDC: | 58160-821-48 |
| Package Description: | 5 SYRINGE in 1 CARTON (58160-821-48) > 1 mL in 1 SYRINGE (58160-821-43) |
| NDC Code | 58160-821-48 |
| Proprietary Name | ENGERIX-B |
| Package Description | 5 SYRINGE in 1 CARTON (58160-821-48) > 1 mL in 1 SYRINGE (58160-821-43) |
| 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 |