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    NDC 63323-0711-00 Leucovorin Calcium 500 mg/50mL Details

    Leucovorin Calcium 500 mg/50mL

    Leucovorin Calcium is a INTRAMUSCULAR; INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is LEUCOVORIN CALCIUM.

    Product Information

    NDC 63323-0711
    Product ID 63323-711_2497bd71-0f85-48ec-9353-d591e1c728f8
    Associated GPIs 21755040102170
    GCN Sequence Number 044542
    GCN Sequence Number Description leucovorin calcium VIAL 500 MG INJECTION
    HIC3 V1I
    HIC3 Description CHEMOTHERAPY RESCUE/ANTIDOTE AGENTS
    GCN 87563
    HICL Sequence Number 001063
    HICL Sequence Number Description LEUCOVORIN CALCIUM
    Brand/Generic Generic
    Proprietary Name Leucovorin Calcium
    Proprietary Name Suffix n/a
    Non-Proprietary Name LEUCOVORIN CALCIUM
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
    Route INTRAMUSCULAR; INTRAVENOUS
    Active Ingredient Strength 500
    Active Ingredient Units mg/50mL
    Substance Name LEUCOVORIN CALCIUM
    Labeler Name Fresenius Kabi USA, LLC
    Pharmaceutical Class Folate Analog [EPC], Folic Acid [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA040286
    Listing Certified Through 2024-12-31

    Package

    NDC 63323-0711-00 (63323071100)

    NDC Package Code 63323-711-00
    Billing NDC 63323071100
    Package 1 VIAL in 1 BOX (63323-711-00) / 50 mL in 1 VIAL
    Marketing Start Date 2010-09-18
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL e3b957dc-a542-4f69-b8a0-7df401ee706f Details

    Revised: 3/2022