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NDC 00006-4109-09 GARDASIL 40; 40; 20; 20 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Details
GARDASIL 40; 40; 20; 20 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
GARDASIL is a INTRAMUSCULAR INJECTION, SUSPENSION in the VACCINE category. It is labeled and distributed by Merck Sharp & Dohme LLC. The primary component is 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.
Product Information
| NDC | 00006-4109 |
|---|---|
| Product ID | 0006-4109_29df93f8-318f-4348-810f-3836352720ee |
| Associated GPIs | |
| GCN Sequence Number | 060970 |
| GCN Sequence Number Description | human papilomvirus vac,qval/PF SYRINGE 20-40/0.5 INTRAMUSC |
| HIC3 | W7B |
| HIC3 Description | VIRAL/TUMORIGENIC VACCINES |
| GCN | 27125 |
| HICL Sequence Number | 035081 |
| HICL Sequence Number Description | HUMAN PAPILLOMAVIRUS VACCINE, QUADRIVALENT/PF |
| Brand/Generic | Brand |
| Proprietary Name | GARDASIL |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant |
| Product Type | VACCINE |
| Dosage Form | INJECTION, SUSPENSION |
| Route | INTRAMUSCULAR |
| Active Ingredient Strength | 40; 40; 20; 20 |
| Active Ingredient Units | ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL |
| 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 |
| Labeler Name | Merck Sharp & Dohme LLC |
| Pharmaceutical Class | Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Inactivated Human Papillomavirus Vaccine [EPC], Inactivated Human Papillomavirus Vaccine [EPC], Inactivated Human Papilloma |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA125126 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00006-4109-09 (00006410909)
| NDC Package Code | 0006-4109-09 |
|---|---|
| Billing NDC | 00006410909 |
| Package | 6 SYRINGE in 1 CARTON (0006-4109-09) / .5 mL in 1 SYRINGE (0006-4109-01) |
| Marketing Start Date | 2006-06-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |