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    NDC 62332-0061-31 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 Alembic Pharmaceuticals Inc.. The primary component is LEFLUNOMIDE.

    Product Information

    NDC 62332-0061
    Product ID 62332-061_3d4cd663-0668-4504-8eb4-7cc73278dea7
    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 Alembic Pharmaceuticals Inc.
    Pharmaceutical Class Antirheumatic Agent [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA091369
    Listing Certified Through 2024-12-31

    Package

    NDC 62332-0061-31 (62332006131)

    NDC Package Code 62332-061-31
    Billing NDC 62332006131
    Package 100 TABLET in 1 BOTTLE (62332-061-31)
    Marketing Start Date 2016-12-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL c288d1d3-3fbe-4c34-a28a-923d515809b3 Details

    Revised: 10/2021