| Product NDC: | 68258-3042 | 
| 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: | 68258-3042 | 
| Labeler Name: | Dispensing Solutions Inc. | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | BLA103239 | 
| Marketing Category: | BLA | 
| Start Marketing Date: | 20090528 | 
| Package NDC: | 68258-3042-1 | 
| Package Description: | 1 VIAL in 1 CARTON (68258-3042-1) > 1 mL in 1 VIAL | 
| NDC Code | 68258-3042-1 | 
| Proprietary Name | ENGERIX-B | 
| Package Description | 1 VIAL in 1 CARTON (68258-3042-1) > 1 mL in 1 VIAL | 
| Product NDC | 68258-3042 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | Hepatitis B Vaccine (Recombinant) | 
| Dosage Form Name | INJECTION, SUSPENSION | 
| Route Name | INTRAMUSCULAR | 
| Start Marketing Date | 20090528 | 
| Marketing Category Name | BLA | 
| Labeler Name | Dispensing Solutions Inc. | 
| Substance Name | HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN | 
| Strength Number | 20 | 
| Strength Unit | ug/mL | 
| Pharmaceutical Classes |