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    NDC 43598-0885-15 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 43598-0885
    Product ID 43598-885_195f48e7-53f4-e6a7-a61e-f4a0b9e2a6a9
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    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 43598-0885-15 (43598088515)

    NDC Package Code 43598-885-15
    Billing NDC 43598088515
    Package 1 TUBE in 1 CARTON (43598-885-15) / 150 g in 1 TUBE
    Marketing Start Date 2021-01-31
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL c88b2512-0255-658d-252a-c006275159b0 Details

    Revised: 1/2022