{
  "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": "19",
          "submission_status": "AP",
          "submission_status_date": "20140923",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20110802",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20100317",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20091228",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "34",
          "submission_status": "AP",
          "submission_status_date": "20201103",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "32",
          "submission_status": "AP",
          "submission_status_date": "20180816",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20140923",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20110728",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20040211",
          "application_docs": [
            {
              "id": "8936",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76631ltr.pdf",
              "date": "20040212",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20090831",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "37",
          "submission_status": "AP",
          "submission_status_date": "20201103",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "29",
          "submission_status": "AP",
          "submission_status_date": "20160324",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20070925",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "20150630",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA076631",
      "sponsor_name": "SANDOZ",
      "openfda": {
        "application_number": [
          "ANDA076631"
        ],
        "brand_name": [
          "BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE"
        ],
        "generic_name": [
          "BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE"
        ],
        "manufacturer_name": [
          "Sandoz Inc",
          "Glenmark Pharmaceuticals Inc., USA"
        ],
        "product_ndc": [
          "0185-0211",
          "0185-0236",
          "0185-0325",
          "0185-0277",
          "68462-576",
          "68462-577",
          "68462-578",
          "68462-579"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BENAZEPRIL HYDROCHLORIDE",
          "HYDROCHLOROTHIAZIDE"
        ],
        "rxcui": [
          "898362",
          "898367",
          "898372",
          "898378"
        ],
        "spl_id": [
          "d9ded9f8-b60e-4325-a813-44b5ee485acc",
          "51b0aed8-a229-4d2c-8fdf-aa957fddc41b"
        ],
        "spl_set_id": [
          "c9bdfbb4-87b6-4de4-bc1d-5025d3ef591f",
          "51b0aed8-a229-4d2c-8fdf-aa957fddc41b"
        ],
        "package_ndc": [
          "0185-0236-01",
          "0185-0325-01",
          "0185-0211-01",
          "0185-0277-01",
          "68462-576-01",
          "68462-577-01",
          "68462-578-01",
          "68462-579-01"
        ],
        "nui": [
          "N0000175359",
          "N0000175419",
          "M0471776"
        ],
        "pharm_class_pe": [
          "Increased Diuresis [PE]"
        ],
        "pharm_class_epc": [
          "Thiazide Diuretic [EPC]"
        ],
        "pharm_class_cs": [
          "Thiazides [CS]"
        ],
        "unii": [
          "0J48LPH2TH",
          "N1SN99T69T"
        ]
      },
      "products": [
        {
          "product_number": "003",
          "reference_drug": "No",
          "brand_name": "BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE",
          "active_ingredients": [
            {
              "name": "BENAZEPRIL HYDROCHLORIDE",
              "strength": "20MG"
            },
            {
              "name": "HYDROCHLOROTHIAZIDE",
              "strength": "12.5MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE",
          "active_ingredients": [
            {
              "name": "BENAZEPRIL HYDROCHLORIDE",
              "strength": "5MG"
            },
            {
              "name": "HYDROCHLOROTHIAZIDE",
              "strength": "6.25MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "004",
          "reference_drug": "No",
          "brand_name": "BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE",
          "active_ingredients": [
            {
              "name": "BENAZEPRIL HYDROCHLORIDE",
              "strength": "20MG"
            },
            {
              "name": "HYDROCHLOROTHIAZIDE",
              "strength": "25MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE",
          "active_ingredients": [
            {
              "name": "BENAZEPRIL HYDROCHLORIDE",
              "strength": "10MG"
            },
            {
              "name": "HYDROCHLOROTHIAZIDE",
              "strength": "12.5MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}