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    NDC 35573-0435-56 Sodium Fluoride 1.1% 5 mg/g Details

    Sodium Fluoride 1.1% 5 mg/g

    Sodium Fluoride 1.1% is a DENTAL GEL, DENTIFRICE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Burel Pharmaceuticals LLC. The primary component is SODIUM FLUORIDE.

    Product Information

    NDC 35573-0435
    Product ID 35573-435_0de90332-2887-482b-8787-1fbbc6500c00
    Associated GPIs 88402020004020
    GCN Sequence Number 002607
    GCN Sequence Number Description fluoride (sodium) GEL (GRAM) 1.1 % DENTAL
    HIC3 D2A
    HIC3 Description FLUORIDE PREPARATIONS
    GCN 07358
    HICL Sequence Number 001127
    HICL Sequence Number Description FLUORIDE (SODIUM)
    Brand/Generic Generic
    Proprietary Name Sodium Fluoride 1.1%
    Proprietary Name Suffix n/a
    Non-Proprietary Name Sodium Fluoride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form GEL, DENTIFRICE
    Route DENTAL
    Active Ingredient Strength 5
    Active Ingredient Units mg/g
    Substance Name SODIUM FLUORIDE
    Labeler Name Burel Pharmaceuticals LLC
    Pharmaceutical Class n/a
    DEA Schedule n/a
    Marketing Category UNAPPROVED DRUG OTHER
    Application Number n/a
    Listing Certified Through 2024-12-31

    Package

    NDC 35573-0435-56 (35573043556)

    NDC Package Code 35573-435-56
    Billing NDC 35573043556
    Package 1 TUBE in 1 CARTON (35573-435-56) / 56 g in 1 TUBE
    Marketing Start Date 2020-02-28
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 0.13416
    Pricing Unit GM
    Effective Date 2024-02-21
    NDC Description SODIUM FLUORIDE 1.1% GEL
    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