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: | 58160-830-52 |
Package Description: | 10 SYRINGE in 1 CARTON (58160-830-52) > .5 mL in 1 SYRINGE (58160-830-43) |
NDC Code | 58160-830-52 |
Proprietary Name | CERVARIX |
Package Description | 10 SYRINGE in 1 CARTON (58160-830-52) > .5 mL in 1 SYRINGE (58160-830-43) |
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 |