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    NDC 45802-0009-10 Fluocinolone Acetonide 0.11 mg/mL Details

    Fluocinolone Acetonide 0.11 mg/mL

    Fluocinolone Acetonide is a AURICULAR (OTIC) SOLUTION/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. The primary component is FLUOCINOLONE ACETONIDE.

    Product Information

    NDC 45802-0009
    Product ID 45802-009_411adaf8-ab23-416a-b452-84ae6ee836e1
    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 SOLUTION/ DROPS
    Route AURICULAR (OTIC)
    Active Ingredient Strength 0.11
    Active Ingredient Units mg/mL
    Substance Name FLUOCINOLONE ACETONIDE
    Labeler Name Padagis Israel Pharmaceuticals Ltd
    Pharmaceutical Class Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA202849
    Listing Certified Through 2024-12-31

    Package

    NDC 45802-0009-10 (45802000910)

    NDC Package Code 45802-009-10
    Billing NDC 45802000910
    Package 1 BOTTLE in 1 CARTON (45802-009-10) / 20 mL in 1 BOTTLE
    Marketing Start Date 2017-10-04
    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