{
  "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": "2026-06-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 8
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Bosentan Bosentan BOSENTAN BOSENTAN ANHYDROUS ETHYLCELLULOSE, UNSPECIFIED FERRIC OXIDE RED FERRIC OXIDE YELLOW GLYCERYL DIBEHENATE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE POVIDONE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN TALC TITANIUM DIOXIDE TRIACETIN LIGHT PINK BICONVEX 446 Bosentan Bosentan BOSENTAN BOSENTAN ANHYDROUS ETHYLCELLULOSE, UNSPECIFIED FERRIC OXIDE RED FERRIC OXIDE YELLOW GLYCERYL DIBEHENATE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE POVIDONE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN TALC TITANIUM DIOXIDE TRIACETIN LIGHT PINK BICONVEX 447"
      ],
      "spl_unclassified_section": [
        ""
      ],
      "spl_medguide": [
        "SPL MEDGUIDE"
      ],
      "package_label_principal_display_panel": [
        "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1017-6 Bosentan tablets, 62.5 mg 60 tablets Rx only NDC 70771-1018-6 Bosentan tablets, 125 mg 60 tablets Rx only Bosentan tablets Bosentan tablets"
      ],
      "set_id": "02892f47-0d59-4254-9ee7-d524278fdd79",
      "id": "33935d05-c8ff-4d9e-91bf-fac9072d25fd",
      "effective_time": "20241125",
      "version": "6",
      "openfda": {
        "application_number": [
          "ANDA207760"
        ],
        "brand_name": [
          "Bosentan"
        ],
        "generic_name": [
          "BOSENTAN"
        ],
        "manufacturer_name": [
          "Zydus Lifesciences Limited"
        ],
        "product_ndc": [
          "70771-1017",
          "70771-1018"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BOSENTAN"
        ],
        "rxcui": [
          "349253",
          "656659"
        ],
        "spl_id": [
          "33935d05-c8ff-4d9e-91bf-fac9072d25fd"
        ],
        "spl_set_id": [
          "02892f47-0d59-4254-9ee7-d524278fdd79"
        ],
        "package_ndc": [
          "70771-1017-6",
          "70771-1017-1",
          "70771-1017-8",
          "70771-1017-5",
          "70771-1017-2",
          "70771-1017-4",
          "70771-1018-6",
          "70771-1018-1",
          "70771-1018-8",
          "70771-1018-5",
          "70771-1018-2",
          "70771-1018-4"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "Q326023R30"
        ]
      }
    }
  ]
}