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    NDC 43598-0977-10 DICLOFENAC SODIUM 10 mg/g Details

    DICLOFENAC SODIUM 10 mg/g

    DICLOFENAC SODIUM is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Dr. Reddy's Laboratories Inc.. The primary component is DICLOFENAC SODIUM.

    Product Information

    NDC 43598-0977
    Product ID 43598-977_3cedceee-935b-4ad4-3a4b-b091fba59b0e
    Associated GPIs 90210030304020
    GCN Sequence Number 018293
    GCN Sequence Number Description diclofenac sodium GEL (GRAM) 1 % TOPICAL
    HIC3 Q5E
    HIC3 Description TOPICAL ANTI-INFLAMMATORY, NSAIDS
    GCN 45680
    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 topical gel, 1%
    Product Type HUMAN OTC DRUG
    Dosage Form GEL
    Route TOPICAL
    Active Ingredient Strength 10
    Active Ingredient Units mg/g
    Substance Name DICLOFENAC SODIUM
    Labeler Name Dr. Reddy's Laboratories 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 ANDA210986
    Listing Certified Through 2024-12-31

    Package

    NDC 43598-0977-10 (43598097710)

    NDC Package Code 43598-977-10
    Billing NDC 43598097710
    Package 1 TUBE in 1 CARTON (43598-977-10) / 100 g in 1 TUBE
    Marketing Start Date 2020-09-14
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 0.10286
    Pricing Unit GM
    Effective Date 2024-02-21
    NDC Description DICLOFENAC SODIUM 1% GEL
    Pharmacy Type Indicator C/I
    OTC Y
    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 03abebd6-426a-9d05-3dff-196477389430 Details

    Revised: 1/2021