| 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: | 0006-4045-41 |
| Package Description: | 10 VIAL, SINGLE-DOSE in 1 CARTON (0006-4045-41) > .5 mL in 1 VIAL, SINGLE-DOSE (0006-4045-01) |
| NDC Code | 0006-4045-41 |
| Proprietary Name | GARDASIL |
| Package Description | 10 VIAL, SINGLE-DOSE in 1 CARTON (0006-4045-41) > .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] |