{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078314"
        ],
        "brand_name": [
          "NAPROXEN SODIUM"
        ],
        "generic_name": [
          "NAPROXEN SODIUM"
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        "manufacturer_name": [
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        "product_ndc": [
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          "68462-188",
          "68462-189",
          "68462-190",
          "68462-179"
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        "product_type": [
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        "rxcui": [
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          "198013",
          "198014",
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          "68462-189-01",
          "68462-189-05",
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          "68462-190-50",
          "68462-190-01",
          "68462-190-05",
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          "68462-178-05",
          "68462-179-01",
          "68462-179-05"
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        "is_original_packager": [
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          "0368462190012"
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        "nui": [
          "N0000000160",
          "M0001335",
          "N0000175722"
        ],
        "pharm_class_moa": [
          "Cyclooxygenase Inhibitors [MoA]"
        ],
        "pharm_class_cs": [
          "Anti-Inflammatory Agents, Non-Steroidal [CS]"
        ],
        "pharm_class_epc": [
          "Nonsteroidal Anti-inflammatory Drug [EPC]"
        ],
        "unii": [
          "57Y76R9ATQ",
          "9TN87S3A3C"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93368",
      "recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
      "address_1": "750 Corporate Dr",
      "address_2": "",
      "postal_code": "07430-2009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0124-2024",
      "product_description": "Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-188-01.",
      "product_quantity": "",
      "reason_for_recall": "Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen",
      "recall_initiation_date": "20231107",
      "center_classification_date": "20231127",
      "report_date": "20231206",
      "code_info": "Lot# 19231903; Exp 4/2025 Lot# 19231858; Exp 4/2025 Lot# 19231881; Exp 4/2025 Lot# 19233484: Exp 8/2025 Lot# 19233490; Exp 8/2025",
      "more_code_info": ""
    }
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}