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    NDC 42291-0420-30 LEFLUNOMIDE 10 mg/1 Details

    LEFLUNOMIDE 10 mg/1

    LEFLUNOMIDE is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AvKARE. The primary component is LEFLUNOMIDE.

    Product Information

    NDC 42291-0420
    Product ID 42291-420_0e8fcbb3-196d-92c2-e063-6294a90a392b
    Associated GPIs 66280050000310
    GCN Sequence Number 040549
    GCN Sequence Number Description leflunomide TABLET 10 MG ORAL
    HIC3 S2I
    HIC3 Description ANTI-INFLAMMATORY, PYRIMIDINE SYNTHESIS INHIBITOR
    GCN 67031
    HICL Sequence Number 018694
    HICL Sequence Number Description LEFLUNOMIDE
    Brand/Generic Generic
    Proprietary Name LEFLUNOMIDE
    Proprietary Name Suffix n/a
    Non-Proprietary Name LEFLUNOMIDE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 10
    Active Ingredient Units mg/1
    Substance Name LEFLUNOMIDE
    Labeler Name AvKARE
    Pharmaceutical Class Antirheumatic Agent [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA077090
    Listing Certified Through 2025-12-31

    Package

    NDC 42291-0420-30 (42291042030)

    NDC Package Code 42291-420-30
    Billing NDC 42291042030
    Package 30 TABLET in 1 BOTTLE (42291-420-30)
    Marketing Start Date 2019-06-13
    NDC Exclude Flag N
    Pricing Information N/A