{
  "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": "20190326",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        }
      ],
      "application_number": "ANDA209744",
      "sponsor_name": "AMNEAL PHARMS CO",
      "openfda": {
        "application_number": [
          "ANDA209744"
        ],
        "brand_name": [
          "TADALAFIL"
        ],
        "generic_name": [
          "TADALAFIL"
        ],
        "manufacturer_name": [
          "Amneal Pharmaceuticals NY LLC",
          "AvKARE"
        ],
        "product_ndc": [
          "69238-1346",
          "69238-1347",
          "69238-1348",
          "69238-1349",
          "42291-864",
          "42291-865",
          "42291-866",
          "42291-867",
          "60219-1346",
          "60219-1347",
          "60219-1348",
          "60219-1349"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TADALAFIL"
        ],
        "rxcui": [
          "402019",
          "403957",
          "484814",
          "757707"
        ],
        "spl_id": [
          "5c6a682e-8bbe-4e9c-914c-148a5a0cb2a4",
          "488420ae-b4b6-d0ab-e063-6394a90a89bf",
          "826351a8-9666-447a-beca-40027a773f2b"
        ],
        "spl_set_id": [
          "90f38460-62ad-492e-a3da-403d5a5a5d86",
          "b96ae7f1-7d4a-a211-e053-2995a90ab6e2",
          "2cad2167-dbd1-4df8-b407-b270487d027b"
        ],
        "package_ndc": [
          "69238-1346-3",
          "69238-1347-3",
          "69238-1348-3",
          "69238-1349-3",
          "42291-864-30",
          "42291-865-30",
          "42291-866-30",
          "42291-867-30",
          "60219-1346-3",
          "60219-1347-3",
          "60219-1348-3",
          "60219-1349-3"
        ],
        "nui": [
          "N0000175599",
          "N0000020026"
        ],
        "pharm_class_epc": [
          "Phosphodiesterase 5 Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Phosphodiesterase 5 Inhibitors [MoA]"
        ],
        "unii": [
          "742SXX0ICT"
        ]
      },
      "products": [
        {
          "product_number": "003",
          "reference_drug": "No",
          "brand_name": "TADALAFIL",
          "active_ingredients": [
            {
              "name": "TADALAFIL",
              "strength": "10MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB1"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "TADALAFIL",
          "active_ingredients": [
            {
              "name": "TADALAFIL",
              "strength": "2.5MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB1"
        },
        {
          "product_number": "004",
          "reference_drug": "No",
          "brand_name": "TADALAFIL",
          "active_ingredients": [
            {
              "name": "TADALAFIL",
              "strength": "20MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB1"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "TADALAFIL",
          "active_ingredients": [
            {
              "name": "TADALAFIL",
              "strength": "5MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB1"
        }
      ]
    }
  ]
}