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    NDC 68180-0538-01 Diclofenac Sodium 16.05 mg/mL Details

    Diclofenac Sodium 16.05 mg/mL

    Diclofenac Sodium is a TOPICAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is DICLOFENAC SODIUM.

    Product Information

    NDC 68180-0538
    Product ID 68180-538_cf519ecb-f36c-409b-a376-4d7514075aa0
    Associated GPIs 90210030302025
    GCN Sequence Number 051971
    GCN Sequence Number Description diclofenac sodium DROPS 1.5 % TOPICAL
    HIC3 Q5E
    HIC3 Description TOPICAL ANTI-INFLAMMATORY, NSAIDS
    GCN 19454
    HICL Sequence Number 003733
    HICL Sequence Number Description DICLOFENAC SODIUM
    Brand/Generic Generic
    Proprietary Name Diclofenac Sodium
    Proprietary Name Suffix n/a
    Non-Proprietary Name Diclofenac Sodium
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SOLUTION
    Route TOPICAL
    Active Ingredient Strength 16.05
    Active Ingredient Units mg/mL
    Substance Name DICLOFENAC SODIUM
    Labeler Name Lupin Pharmaceuticals, Inc.
    Pharmaceutical Class Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA204132
    Listing Certified Through 2024-12-31

    Package

    NDC 68180-0538-01 (68180053801)

    NDC Package Code 68180-538-01
    Billing NDC 68180053801
    Package 1 BOTTLE, DROPPER in 1 CARTON (68180-538-01) / 150 mL in 1 BOTTLE, DROPPER
    Marketing Start Date 2016-07-06
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 0.15663
    Pricing Unit ML
    Effective Date 2024-01-17
    NDC Description DICLOFENAC 1.5% TOPICAL SOLN
    Pharmacy Type Indicator C/I
    OTC N
    Explanation Code 4, 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