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NDC 00006-4121-02 GARDASIL 9 40; 60; 40; 20; 20; 20; 20; 20; 30 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Details
GARDASIL 9 40; 60; 40; 20; 20; 20; 20; 20; 30 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
GARDASIL 9 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 31 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 33 L1.
Product Information
| NDC | 00006-4121 |
|---|---|
| Product ID | 0006-4121_24b02bdc-d842-4667-93c5-b5ddfac71ab8 |
| Associated GPIs | 1710006550E600 |
| GCN Sequence Number | 073200 |
| GCN Sequence Number Description | HPV vaccine 9-valent/PF SYRINGE 0.5 ML INTRAMUSC |
| HIC3 | W7B |
| HIC3 Description | VIRAL/TUMORIGENIC VACCINES |
| GCN | 37568 |
| HICL Sequence Number | 041619 |
| HICL Sequence Number Description | HUMAN PAPILLOMAVIRUS VACCINE, 9-VALENT/PF |
| Brand/Generic | Brand |
| Proprietary Name | GARDASIL 9 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Human Papillomavirus 9-valent Vaccine, Recombinant |
| Product Type | VACCINE |
| Dosage Form | INJECTION, SUSPENSION |
| Route | INTRAMUSCULAR |
| Active Ingredient Strength | 40; 60; 40; 20; 20; 20; 20; 20; 30 |
| Active Ingredient Units | ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; 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 31 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 33 L1 |
| 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 | BLA125508 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00006-4121-02 (00006412102)
| NDC Package Code | 0006-4121-02 |
|---|---|
| Billing NDC | 00006412102 |
| Package | 10 SYRINGE, GLASS in 1 CARTON (0006-4121-02) / .5 mL in 1 SYRINGE, GLASS (0006-4121-01) |
| Marketing Start Date | 2014-12-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |