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    NDC 16714-0178-01 Fluorouracil 50 mg/g Details

    Fluorouracil 50 mg/g

    Fluorouracil is a TOPICAL CREAM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by NORTHSTAR RX LLC. The primary component is FLUOROURACIL.

    Product Information

    NDC 16714-0178
    Product ID 16714-178_7106b404-bb4d-43e4-9809-17bd2e95a63b
    Associated GPIs 90372030003730
    GCN Sequence Number 007502
    GCN Sequence Number Description fluorouracil CREAM (G) 5 % TOPICAL
    HIC3 Q5N
    HIC3 Description TOPICAL ANTINEOPLASTIC PREMALIGNANT LESION AGENTS
    GCN 30781
    HICL Sequence Number 003907
    HICL Sequence Number Description FLUOROURACIL
    Brand/Generic Generic
    Proprietary Name Fluorouracil
    Proprietary Name Suffix n/a
    Non-Proprietary Name Fluorouracil
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CREAM
    Route TOPICAL
    Active Ingredient Strength 50
    Active Ingredient Units mg/g
    Substance Name FLUOROURACIL
    Labeler Name NORTHSTAR RX LLC
    Pharmaceutical Class Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA090368
    Listing Certified Through 2024-12-31

    Package

    NDC 16714-0178-01 (16714017801)

    NDC Package Code 16714-178-01
    Billing NDC 16714017801
    Package 1 TUBE in 1 CARTON (16714-178-01) / 40 g in 1 TUBE
    Marketing Start Date 2021-11-30
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 0.76114
    Pricing Unit GM
    Effective Date 2024-02-21
    NDC Description FLUOROURACIL 5% CREAM
    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

    Standard Product Labeling (SPL)/Prescribing Information SPL 52ef5f41-2312-4b55-aa86-abd5bb28b9d3 Details

    Revised: 12/2021