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    NDC 63868-0730-01 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 Chain Drug Marketing Association INC. The primary component is DICLOFENAC SODIUM.

    Product Information

    NDC 63868-0730
    Product ID 63868-730_58780bd4-1647-8277-175e-b3ad270e0e0e
    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 Chain Drug Marketing Association 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 63868-0730-01 (63868073001)

    NDC Package Code 63868-730-01
    Billing NDC 63868073001
    Package 1 TUBE in 1 CARTON (63868-730-01) / 100 g in 1 TUBE
    Marketing Start Date 2020-09-26
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 625d21e8-0731-1157-30fe-9f9868ff8dc4 Details

    Revised: 10/2020