{
  "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": "2026-08-21",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20111223"
        }
      ],
      "application_number": "ANDA202300",
      "sponsor_name": "AMNEAL PHARMS",
      "openfda": {
        "application_number": [
          "ANDA202300"
        ],
        "brand_name": [
          "IBUPROFEN PAIN RELIEVER/FEVER REDUCER",
          "IBUPROFEN"
        ],
        "generic_name": [
          "IBUPROFEN"
        ],
        "manufacturer_name": [
          "Amneal Pharmaceuticals LLC",
          "P & L Development, LLC",
          "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)"
        ],
        "product_ndc": [
          "65162-770",
          "59726-123",
          "55910-830",
          "65162-356"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "IBUPROFEN"
        ],
        "rxcui": [
          "310964"
        ],
        "spl_id": [
          "7eec8df5-4a15-47be-9031-3e046204d452",
          "59151400-570d-4c78-ba7f-52c84cf864ec",
          "f1afb906-0fa9-4441-84f6-f4b34944dc3c",
          "53da63da-f301-44dc-902c-2c288304929f"
        ],
        "spl_set_id": [
          "5f27dd3f-c735-417b-95e6-26dc5aae5a7a",
          "1889faea-24a3-45ea-92de-8dc76b9ed5b4",
          "7d544d8e-fa76-461f-9417-5f1873912eac",
          "877440fc-3afb-4123-a2e6-5cb48c74413c"
        ],
        "package_ndc": [
          "65162-770-02",
          "65162-770-69",
          "65162-770-50",
          "65162-770-11",
          "59726-123-16",
          "55910-830-80",
          "55910-830-40",
          "55910-830-20",
          "55910-830-12",
          "55910-830-21",
          "65162-356-02",
          "65162-356-69",
          "65162-356-50",
          "65162-356-11"
        ],
        "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": [
          "WK2XYI10QM"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "IBUPROFEN",
          "active_ingredients": [
            {
              "name": "IBUPROFEN",
              "strength": "EQ 200MG FREE ACID AND POTASSIUM SALT"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Over-the-counter"
        }
      ]
    }
  ]
}