{
  "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": "2026-05-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20070608"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20150921",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20071129",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA065409",
      "sponsor_name": "AUROBINDO PHARMA LTD",
      "openfda": {
        "application_number": [
          "ANDA065409"
        ],
        "brand_name": [
          "CEFPODOXIME PROXETIL"
        ],
        "generic_name": [
          "CEFPODOXIME PROXETIL"
        ],
        "manufacturer_name": [
          "Aurobindo Pharma Limited",
          "Rising Pharma Holdings, Inc.",
          "NorthStar Rx LLC"
        ],
        "product_ndc": [
          "65862-140",
          "65862-141",
          "64980-402",
          "64980-403",
          "16714-402",
          "16714-403"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CEFPODOXIME PROXETIL"
        ],
        "rxcui": [
          "309077",
          "309079"
        ],
        "spl_id": [
          "95331369-8343-4244-8d82-03a1bc4af0c0",
          "803b37ff-46c6-4dcb-9d9f-a118c4c4601b",
          "3c3d4973-bfda-476f-b094-52ac4648d7f8"
        ],
        "spl_set_id": [
          "63777889-d306-4fc3-88da-b24859040ef4",
          "edf589b2-f796-4522-a5e6-2bd0a833922f",
          "5310de78-22c3-4bee-9956-854e767b6bef"
        ],
        "package_ndc": [
          "65862-140-50",
          "65862-140-75",
          "65862-140-01",
          "65862-141-50",
          "65862-141-75",
          "65862-141-01",
          "64980-402-50",
          "64980-402-10",
          "64980-403-50",
          "64980-403-10",
          "16714-402-01",
          "16714-402-02",
          "16714-403-01",
          "16714-403-02"
        ],
        "unii": [
          "2TB00A1Z7N"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "CEFPODOXIME PROXETIL",
          "active_ingredients": [
            {
              "name": "CEFPODOXIME PROXETIL",
              "strength": "EQ 50MG BASE/5ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "FOR SUSPENSION",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "CEFPODOXIME PROXETIL",
          "active_ingredients": [
            {
              "name": "CEFPODOXIME PROXETIL",
              "strength": "EQ 100MG BASE/5ML"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "FOR SUSPENSION",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}