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    NDC 00008-1030-06 Rapamune 1 mg/mL Details

    Rapamune 1 mg/mL

    Rapamune is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.. The primary component is SIROLIMUS.

    Product Information

    NDC 00008-1030
    Product ID 0008-1030_59172404-9534-45d4-90a6-1aa6c42f7898
    Associated GPIs 99404070002020
    GCN Sequence Number 043458
    GCN Sequence Number Description sirolimus SOLUTION 1 MG/ML ORAL
    HIC3 Z2E
    HIC3 Description IMMUNOSUPPRESSIVES
    GCN 50356
    HICL Sequence Number 020519
    HICL Sequence Number Description SIROLIMUS
    Brand/Generic Brand
    Proprietary Name Rapamune
    Proprietary Name Suffix n/a
    Non-Proprietary Name SIROLIMUS
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SOLUTION
    Route ORAL
    Active Ingredient Strength 1
    Active Ingredient Units mg/mL
    Substance Name SIROLIMUS
    Labeler Name Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
    Pharmaceutical Class Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA021083
    Listing Certified Through 2024-12-31

    Package

    NDC 00008-1030-06 (00008103006)

    NDC Package Code 0008-1030-06
    Billing NDC 00008103006
    Package 1 CARTON in 1 KIT (0008-1030-06) / 1 BOTTLE, GLASS in 1 CARTON (0008-1030-04) / 60 mL in 1 BOTTLE, GLASS
    Marketing Start Date 1999-09-01
    NDC Exclude Flag N
    Pricing Information N/A