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    NDC 76310-0022-01 Proleukin 1.1 mg/mL Details

    Proleukin 1.1 mg/mL

    Proleukin is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Clinigen Limited. The primary component is ALDESLEUKIN.

    Product Information

    NDC 76310-0022
    Product ID 76310-022_7032fe1c-0860-4bd1-bee9-245f3a825dee
    Associated GPIs 21703020002120
    GCN Sequence Number 016805
    GCN Sequence Number Description aldesleukin VIAL 22MM UNIT INTRAVEN
    HIC3 Z2G
    HIC3 Description IMMUNOMODULATORS
    GCN 49031
    HICL Sequence Number 006402
    HICL Sequence Number Description ALDESLEUKIN
    Brand/Generic Brand
    Proprietary Name Proleukin
    Proprietary Name Suffix n/a
    Non-Proprietary Name aldesleukin
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 1.1
    Active Ingredient Units mg/mL
    Substance Name ALDESLEUKIN
    Labeler Name Clinigen Limited
    Pharmaceutical Class Increased Lymphocyte Activation [PE], Increased Lymphocyte Cell Production [PE], Interleukin-2 [CS], Lymphocyte Growth Factor [EPC]
    DEA Schedule n/a
    Marketing Category BLA
    Application Number BLA103293
    Listing Certified Through 2024-12-31

    Package

    NDC 76310-0022-01 (76310002201)

    NDC Package Code 76310-022-01
    Billing NDC 76310002201
    Package 1 VIAL, SINGLE-DOSE in 1 CARTON (76310-022-01) / 1 mL in 1 VIAL, SINGLE-DOSE
    Marketing Start Date 2019-12-31
    NDC Exclude Flag N
    Pricing Information N/A