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    NDC 70954-0398-10 Dexamethasone 0.5 mg/1 Details

    Dexamethasone 0.5 mg/1

    Dexamethasone is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by ANI Pharmaceuticals, Inc.. The primary component is DEXAMETHASONE.

    Product Information

    NDC 70954-0398
    Product ID 70954-398_7727b249-ac49-4f6d-9310-9de32c2a03f3
    Associated GPIs
    GCN Sequence Number 006784
    GCN Sequence Number Description dexamethasone TABLET 0.5 MG ORAL
    HIC3 P5A
    HIC3 Description GLUCOCORTICOIDS
    GCN 27422
    HICL Sequence Number 002889
    HICL Sequence Number Description DEXAMETHASONE
    Brand/Generic Generic
    Proprietary Name Dexamethasone
    Proprietary Name Suffix n/a
    Non-Proprietary Name Dexamethasone
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 0.5
    Active Ingredient Units mg/1
    Substance Name DEXAMETHASONE
    Labeler Name ANI Pharmaceuticals, Inc.
    Pharmaceutical Class Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA215604
    Listing Certified Through 2024-12-31

    Package

    NDC 70954-0398-10 (70954039810)

    NDC Package Code 70954-398-10
    Billing NDC 70954039810
    Package 100 TABLET in 1 BOTTLE (70954-398-10)
    Marketing Start Date 2023-10-09
    NDC Exclude Flag N
    Pricing Information N/A