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    NDC 69639-0120-01 VALCHLOR 0.012 g/60g Details

    VALCHLOR 0.012 g/60g

    VALCHLOR is a TOPICAL GEL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Helsinn Therapeutics (U.S.), Inc.. The primary component is MECHLORETHAMINE.

    Product Information

    NDC 69639-0120
    Product ID 69639-120_d070f59c-df60-4c99-ac38-6434a70a977d
    Associated GPIs 90371050204030
    GCN Sequence Number 071531
    GCN Sequence Number Description mechlorethamine HCl GEL (GRAM) 0.016 % TOPICAL
    HIC3 Q5N
    HIC3 Description TOPICAL ANTINEOPLASTIC PREMALIGNANT LESION AGENTS
    GCN 35387
    HICL Sequence Number 003892
    HICL Sequence Number Description MECHLORETHAMINE HCL
    Brand/Generic Brand
    Proprietary Name VALCHLOR
    Proprietary Name Suffix n/a
    Non-Proprietary Name mechlorethamine hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form GEL
    Route TOPICAL
    Active Ingredient Strength 0.012
    Active Ingredient Units g/60g
    Substance Name MECHLORETHAMINE
    Labeler Name Helsinn Therapeutics (U.S.), Inc.
    Pharmaceutical Class Alkylating Activity [MoA], Alkylating Drug [EPC]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA202317
    Listing Certified Through 2024-12-31

    Package

    NDC 69639-0120-01 (69639012001)

    NDC Package Code 69639-120-01
    Billing NDC 69639012001
    Package 1 TUBE in 1 CARTON (69639-120-01) / 60 g in 1 TUBE
    Marketing Start Date 2018-11-08
    NDC Exclude Flag N
    Pricing Information N/A