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    NDC 65162-0702-94 Fluocinolone Acetonide 0.11 mg/20mL Details

    Fluocinolone Acetonide 0.11 mg/20mL

    Fluocinolone Acetonide is a AURICULAR (OTIC) OIL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is FLUOCINOLONE ACETONIDE.

    Product Information

    NDC 65162-0702
    Product ID 65162-702_96b3079f-74e9-49bf-8c0a-76fa4dbe6e88
    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/20mL
    Substance Name FLUOCINOLONE ACETONIDE
    Labeler Name Amneal Pharmaceuticals LLC
    Pharmaceutical Class Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA091306
    Listing Certified Through 2024-12-31

    Package

    NDC 65162-0702-94 (65162070294)

    NDC Package Code 65162-702-94
    Billing NDC 65162070294
    Package 1 BOTTLE in 1 CARTON (65162-702-94) / 20 mL in 1 BOTTLE
    Marketing Start Date 2015-09-22
    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