{
  "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/",
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                "46708-292-31",
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                "46708-292-10"
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              "unii": [
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            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "AROMASIN",
            "drugadministrationroute": "065",
            "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION",
            "actiondrug": "5",
            "activesubstance": {
              "activesubstancename": "EXEMESTANE"
            },
            "openfda": {
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                "NDA020753"
              ],
              "brand_name": [
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              "generic_name": [
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              "manufacturer_name": [
                "Pharmacia & Upjohn Company LLC"
              ],
              "product_ndc": [
                "0009-7663"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "EXEMESTANE"
              ],
              "rxcui": [
                "261317",
                "310261"
              ],
              "spl_id": [
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              "spl_set_id": [
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              "package_ndc": [
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              ],
              "nui": [
                "N0000175563",
                "N0000175080"
              ],
              "pharm_class_epc": [
                "Aromatase Inhibitor [EPC]"
              ],
              "pharm_class_moa": [
                "Aromatase Inhibitors [MoA]"
              ],
              "unii": [
                "NY22HMQ4BX"
              ]
            }
          }
        ]
      }
    }
  ]
}