{
  "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": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20180215",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20180215",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20240501",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20180215",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20040625",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19930712"
        }
      ],
      "application_number": "ANDA062797",
      "sponsor_name": "ISTITUTO BIO ITA SPA",
      "openfda": {
        "application_number": [
          "ANDA062797"
        ],
        "brand_name": [
          "AMPICILLIN"
        ],
        "generic_name": [
          "AMPICILLIN",
          "AMPICILLIN SODIUM"
        ],
        "manufacturer_name": [
          "Civica, Inc.",
          "Fresenius Kabi USA, LLC",
          "NorthStar Rx, LLC"
        ],
        "product_ndc": [
          "72572-017",
          "72572-016",
          "65219-020",
          "65219-014",
          "65219-018",
          "65219-016",
          "72603-454",
          "72603-221",
          "72603-363"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "AMPICILLIN SODIUM"
        ],
        "rxcui": [
          "1721475",
          "1721476",
          "1721473",
          "1721474"
        ],
        "spl_id": [
          "6d84c7a4-10e5-4762-ae14-ab2d3231a367",
          "38c6c088-e4ab-4859-b4d9-89e846cf9d5f",
          "ccfb8b44-c373-40a6-8fc9-afd9584e5970"
        ],
        "spl_set_id": [
          "a194f310-a669-4d8f-8c04-ee9ca01939b1",
          "8dbb4c71-8543-08f1-e053-2995a90af88d",
          "6772d650-9814-49e4-a4ec-0b1a97b837d1"
        ],
        "package_ndc": [
          "72572-016-01",
          "72572-016-10",
          "72572-017-01",
          "72572-017-10",
          "65219-014-01",
          "65219-014-10",
          "65219-018-01",
          "65219-018-10",
          "65219-020-03",
          "65219-020-23",
          "65219-016-01",
          "65219-016-10",
          "72603-221-01",
          "72603-221-10",
          "72603-363-01",
          "72603-363-10",
          "72603-454-01",
          "72603-454-10"
        ],
        "unii": [
          "JFN36L5S8K"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "AMPICILLIN SODIUM",
          "active_ingredients": [
            {
              "name": "AMPICILLIN SODIUM",
              "strength": "EQ 125MG BASE/VIAL"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "AMPICILLIN SODIUM",
          "active_ingredients": [
            {
              "name": "AMPICILLIN SODIUM",
              "strength": "EQ 2GM BASE/VIAL"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}