Product NDC: | 0006-4045 |
Proprietary Name: | GARDASIL |
Non Proprietary Name: | Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant |
Active Ingredient(s): | 40; 40; 20; 20 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL & nbsp; Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant |
Administration Route(s): | INTRAMUSCULAR |
Dosage Form(s): | INJECTION, SUSPENSION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0006-4045 |
Labeler Name: | Merck Sharp & Dohme Corp. |
Product Type: | VACCINE |
FDA Application Number: | BLA125126 |
Marketing Category: | BLA |
Start Marketing Date: | 20060608 |
Package NDC: | 0006-4045-00 |
Package Description: | 1 VIAL, SINGLE-DOSE in 1 CARTON (0006-4045-00) > .5 mL in 1 VIAL, SINGLE-DOSE (0006-4045-01) |
NDC Code | 0006-4045-00 |
Proprietary Name | GARDASIL |
Package Description | 1 VIAL, SINGLE-DOSE in 1 CARTON (0006-4045-00) > .5 mL in 1 VIAL, SINGLE-DOSE (0006-4045-01) |
Product NDC | 0006-4045 |
Product Type Name | VACCINE |
Non Proprietary Name | Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant |
Dosage Form Name | INJECTION, SUSPENSION |
Route Name | INTRAMUSCULAR |
Start Marketing Date | 20060608 |
Marketing Category Name | BLA |
Labeler Name | Merck Sharp & Dohme Corp. |
Substance Name | HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN |
Strength Number | 40; 40; 20; 20 |
Strength Unit | ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL |
Pharmaceutical Classes | Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] |