GARDASIL 9 is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Human Papillomavirus Type 6 L1 Capsid Protein Antigen; 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 31 L1 Capsid Protein Antigen; Human Papillomavirus Type 33 L1 Capsid Protein Antigen; Human Papillomavirus Type 45 L1 Capsid Protein Antigen; Human Papillomavirus Type 52 L1 Capsid Protein Antigen; Human Papillomavirus Type 58 L1 Capsid Protein Antigen.
| Product ID | 0006-4121_0d674450-339d-4e3c-8b41-fce10f2241e3 |
| NDC | 0006-4121 |
| Product Type | Vaccine |
| Proprietary Name | GARDASIL 9 |
| Generic Name | Human Papillomavirus 9-valent Vaccine, Recombinant |
| Dosage Form | Injection, Suspension |
| Route of Administration | INTRAMUSCULAR |
| Marketing Start Date | 2014-12-10 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125508 |
| Labeler Name | Merck Sharp & Dohme Corp. |
| Substance Name | HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN; 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 31 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 33 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 45 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 52 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 58 L1 CAPSID PROTEIN ANTIGEN |
| Active Ingredient Strength | 30 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL |
| Pharm Classes | Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [CS],Vaccines, Inactivated [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2014-12-10 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | BLA |
| Application Number | BLA125508 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2014-12-10 |
| Marketing Category | BLA |
| Application Number | BLA125508 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2014-12-10 |
| Ingredient | Strength |
|---|---|
| HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN | 30 ug/.5mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0006-4119 | GARDASIL 9 | Human Papillomavirus 9-valent Vaccine, Recombinant |
| 0006-4121 | GARDASIL 9 | Human Papillomavirus 9-valent Vaccine, Recombinant |
| 50090-2443 | GARDASIL 9 | Human Papillomavirus 9-valent Vaccine, Recombinant |