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    NDC 68462-0185-56 fluocinolone acetonide 0.11 mg/mL Details

    fluocinolone acetonide 0.11 mg/mL

    fluocinolone acetonide is a AURICULAR (OTIC) OIL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Glenmark Pharmaceuticals Inc., USA. The primary component is FLUOCINOLONE ACETONIDE.

    Product Information

    NDC 68462-0185
    Product ID 68462-185_cc1f615e-6cb2-4721-84c6-e5f170b64d90
    Associated GPIs 87300018101720
    GCN Sequence Number 060055
    GCN Sequence Number Description fluocinolone acetonide oil DROPS 0.01 % OTIC (EAR)
    HIC3 Q8P
    HIC3 Description EAR PREPARATIONS ANTI-INFLAMMATORY
    GCN 26056
    HICL Sequence Number 033338
    HICL Sequence Number Description FLUOCINOLONE ACETONIDE OIL
    Brand/Generic Generic
    Proprietary Name fluocinolone acetonide
    Proprietary Name Suffix n/a
    Non-Proprietary Name fluocinolone acetonide
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form OIL
    Route AURICULAR (OTIC)
    Active Ingredient Strength 0.11
    Active Ingredient Units mg/mL
    Substance Name FLUOCINOLONE ACETONIDE
    Labeler Name Glenmark Pharmaceuticals Inc., USA
    Pharmaceutical Class Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA211815
    Listing Certified Through 2025-12-31

    Package

    NDC 68462-0185-56 (68462018556)

    NDC Package Code 68462-185-56
    Billing NDC 68462018556
    Package 1 BOTTLE, DROPPER in 1 CARTON (68462-185-56) / 20 mL in 1 BOTTLE, DROPPER
    Marketing Start Date 2018-12-18
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 1.31946
    Pricing Unit ML
    Effective Date 2024-02-21
    NDC Description FLUOCINOLONE OIL 0.01% EAR DRP
    Pharmacy Type Indicator C/I
    OTC N
    Explanation Code 1, 5
    Classification for Rate Setting G
    As of Date 2024-02-21
    This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis