Search by Drug Name or NDC

    NDC 68727-0712-01 ZEPZELCA 0.5 mg/mL Details

    ZEPZELCA 0.5 mg/mL

    ZEPZELCA is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Jazz Pharmaceuticals, Inc.. The primary component is LURBINECTEDIN.

    Product Information

    NDC 68727-0712
    Product ID 68727-712_3d667d47-35e9-4eeb-a5a6-2a879f52eac5
    Associated GPIs 21100024002120
    GCN Sequence Number 081197
    GCN Sequence Number Description lurbinectedin VIAL 4 MG INTRAVEN
    HIC3 V1A
    HIC3 Description ANTINEOPLASTIC - ALKYLATING AGENTS
    GCN 48241
    HICL Sequence Number 046626
    HICL Sequence Number Description LURBINECTEDIN
    Brand/Generic Brand
    Proprietary Name ZEPZELCA
    Proprietary Name Suffix n/a
    Non-Proprietary Name Lurbinectedin
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 0.5
    Active Ingredient Units mg/mL
    Substance Name LURBINECTEDIN
    Labeler Name Jazz Pharmaceuticals, Inc.
    Pharmaceutical Class Alkylating Activity [MoA], Alkylating Drug [EPC]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA213702
    Listing Certified Through 2024-12-31

    Package

    NDC 68727-0712-01 (68727071201)

    NDC Package Code 68727-712-01
    Billing NDC 68727071201
    Package 8 mL in 1 VIAL, SINGLE-DOSE (68727-712-01)
    Marketing Start Date 2020-06-15
    NDC Exclude Flag N
    Pricing Information N/A