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    NDC 64980-0331-04 Fluocinolone Acetonide 0.11 mg/mL Details

    Fluocinolone Acetonide 0.11 mg/mL

    Fluocinolone Acetonide is a TOPICAL OIL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Rising Pharmaceuticals, Inc.. The primary component is FLUOCINOLONE ACETONIDE.

    Product Information

    NDC 64980-0331
    Product ID 64980-331_e74fcd7c-2027-43c1-8bcf-7341100646c6
    Associated GPIs 90550055101712
    GCN Sequence Number 007507
    GCN Sequence Number Description fluocinolone acetonide OIL 0.01 % TOPICAL
    HIC3 Q5P
    HIC3 Description TOPICAL ANTI-INFLAMMATORY STEROIDAL
    GCN 85080
    HICL Sequence Number 002896
    HICL Sequence Number Description FLUOCINOLONE ACETONIDE
    Brand/Generic Generic
    Proprietary Name Fluocinolone Acetonide
    Proprietary Name Suffix Oil
    Non-Proprietary Name Fluocinolone Acetonide
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form OIL
    Route TOPICAL
    Active Ingredient Strength 0.11
    Active Ingredient Units mg/mL
    Substance Name FLUOCINOLONE ACETONIDE
    Labeler Name Rising Pharmaceuticals, Inc.
    Pharmaceutical Class Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA203377
    Listing Certified Through 2024-12-31

    Package

    NDC 64980-0331-04 (64980033104)

    NDC Package Code 64980-331-04
    Billing NDC 64980033104
    Package 118.28 mL in 1 BOTTLE (64980-331-04)
    Marketing Start Date 2016-07-18
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 0.22782
    Pricing Unit ML
    Effective Date 2024-02-21
    NDC Description FLUOCINOLONE 0.01% BODY OIL
    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