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    NDC 00143-9292-01 Thiotepa 100 mg/1 Details

    Thiotepa 100 mg/1

    Thiotepa is a INTRACAVITARY; INTRAVENOUS; INTRAVESICAL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is THIOTEPA.

    Product Information

    NDC 00143-9292
    Product ID 0143-9292_f18a13d2-83c0-42a1-8980-60b228c23ab9
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    Proprietary Name Thiotepa
    Proprietary Name Suffix n/a
    Non-Proprietary Name Thiotepa
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
    Route INTRACAVITARY; INTRAVENOUS; INTRAVESICAL
    Active Ingredient Strength 100
    Active Ingredient Units mg/1
    Substance Name THIOTEPA
    Labeler Name Hikma Pharmaceuticals USA Inc.
    Pharmaceutical Class Alkylating Activity [MoA], Alkylating Drug [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA211755
    Listing Certified Through 2024-12-31

    Package

    NDC 00143-9292-01 (00143929201)

    NDC Package Code 0143-9292-01
    Billing NDC 00143929201
    Package 1 VIAL in 1 BOX, UNIT-DOSE (0143-9292-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
    Marketing Start Date 2023-09-29
    NDC Exclude Flag N
    Pricing Information N/A