| Product NDC: | 58160-830 |
| Proprietary Name: | CERVARIX |
| Non Proprietary Name: | Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant |
| Active Ingredient(s): | 20; 20 ug/.5mL; ug/.5mL & nbsp; Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant |
| Administration Route(s): | INTRAMUSCULAR |
| Dosage Form(s): | INJECTION, SUSPENSION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 58160-830 |
| Labeler Name: | GlaxoSmithKline Biologicals SA |
| Product Type: | VACCINE |
| FDA Application Number: | BLA125259 |
| Marketing Category: | BLA |
| Start Marketing Date: | 20091016 |
| Package NDC: | 58160-830-46 |
| Package Description: | 5 SYRINGE in 1 CARTON (58160-830-46) > .5 mL in 1 SYRINGE (58160-830-41) |
| NDC Code | 58160-830-46 |
| Proprietary Name | CERVARIX |
| Package Description | 5 SYRINGE in 1 CARTON (58160-830-46) > .5 mL in 1 SYRINGE (58160-830-41) |
| Product NDC | 58160-830 |
| Product Type Name | VACCINE |
| Non Proprietary Name | Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant |
| Dosage Form Name | INJECTION, SUSPENSION |
| Route Name | INTRAMUSCULAR |
| Start Marketing Date | 20091016 |
| Marketing Category Name | BLA |
| Labeler Name | GlaxoSmithKline Biologicals SA |
| Substance Name | HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN RESIDUES 2-471 ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN RESIDUES 2-472 ANTIGEN |
| Strength Number | 20; 20 |
| Strength Unit | ug/.5mL; ug/.5mL |
| Pharmaceutical Classes |