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    NDC 00006-4119-03 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 00006-4119
    Product ID 0006-4119_24b02bdc-d842-4667-93c5-b5ddfac71ab8
    Associated GPIs 17100065501800
    GCN Sequence Number 073199
    GCN Sequence Number Description HPV vaccine 9-valent/PF VIAL 0.5 ML INTRAMUSC
    HIC3 W7B
    HIC3 Description VIRAL/TUMORIGENIC VACCINES
    GCN 37567
    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 00006-4119-03 (00006411903)

    NDC Package Code 0006-4119-03
    Billing NDC 00006411903
    Package 10 VIAL, SINGLE-DOSE in 1 CARTON (0006-4119-03) / .5 mL in 1 VIAL, SINGLE-DOSE (0006-4119-01)
    Marketing Start Date 2014-12-10
    NDC Exclude Flag N
    Pricing Information N/A