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    NDC 00378-8200-01 Ketoprofen 200 mg/1 Details

    Ketoprofen 200 mg/1

    Ketoprofen is a ORAL CAPSULE, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is KETOPROFEN.

    Product Information

    NDC 00378-8200
    Product ID 0378-8200_3faf3996-75bd-4f76-b5f4-9a8d2e5958cc
    Associated GPIs 66100035007030
    GCN Sequence Number 016406
    GCN Sequence Number Description ketoprofen CAP24H PEL 200 MG ORAL
    HIC3 S2B
    HIC3 Description NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS
    GCN 33792
    HICL Sequence Number 003736
    HICL Sequence Number Description KETOPROFEN
    Brand/Generic Generic
    Proprietary Name Ketoprofen
    Proprietary Name Suffix n/a
    Non-Proprietary Name ketoprofen
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 200
    Active Ingredient Units mg/1
    Substance Name KETOPROFEN
    Labeler Name Mylan Pharmaceuticals Inc.
    Pharmaceutical Class Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA075679
    Listing Certified Through 2024-12-31

    Package

    NDC 00378-8200-01 (00378820001)

    NDC Package Code 0378-8200-01
    Billing NDC 00378820001
    Package 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-8200-01)
    Marketing Start Date 2003-09-04
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 198a4140-f4c0-4478-9157-ee1d68d0bb96 Details

    Revised: 3/2021