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NDC 00006-4045-00 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 | 00006-4045 |
|---|---|
| Product ID | 0006-4045_29df93f8-318f-4348-810f-3836352720ee |
| Associated GPIs | |
| GCN Sequence Number | 060969 |
| GCN Sequence Number Description | human papilomvirus vac,qval/PF VIAL 20-40/0.5 INTRAMUSC |
| HIC3 | W7B |
| HIC3 Description | VIRAL/TUMORIGENIC VACCINES |
| GCN | 27124 |
| 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 00006-4045-00 (00006404500)
| NDC Package Code | 0006-4045-00 |
|---|---|
| Billing NDC | 00006404500 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (0006-4045-00) / .5 mL in 1 VIAL, SINGLE-DOSE (0006-4045-01) |
| Marketing Start Date | 2006-06-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |