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    NDC 57896-0140-01 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 GERI-CARE PHARMACEUTICALS CORP. The primary component is DICLOFENAC SODIUM.

    Product Information

    NDC 57896-0140
    Product ID 57896-140_ed8601c1-3c09-e44c-1ac5-7f5b5d7dc650
    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 GERI-CARE PHARMACEUTICALS CORP
    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 57896-0140-01 (57896014001)

    NDC Package Code 57896-140-01
    Billing NDC 57896014001
    Package 1 TUBE in 1 CARTON (57896-140-01) / 100 g in 1 TUBE
    Marketing Start Date 2021-10-05
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 91fc618a-edd0-5944-083f-c00075476f55 Details

    Revised: 10/2021