{
  "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": "2026-10-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "75834-264",
      "generic_name": "diclofenac sodium and misoprostol",
      "labeler_name": "Nivagen Pharmaceuticals, Inc.",
      "brand_name": "Diclofenac Sodium Misoprostol",
      "active_ingredients": [
        {
          "name": "DICLOFENAC SODIUM",
          "strength": "50 mg/1"
        },
        {
          "name": "MISOPROSTOL",
          "strength": "200 ug/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "75834-264-60",
          "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (75834-264-60)",
          "marketing_start_date": "20210715",
          "sample": false
        },
        {
          "package_ndc": "75834-264-90",
          "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (75834-264-90)",
          "marketing_start_date": "20210715",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Nivagen Pharmaceuticals, Inc."
        ],
        "rxcui": [
          "857706",
          "1359105"
        ],
        "spl_set_id": [
          "2acf46ac-8ba8-444d-b421-19d5ad49644c"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0375834264608",
          "0375834265605"
        ],
        "nui": [
          "N0000175785",
          "M0017811"
        ],
        "pharm_class_epc": [
          "Prostaglandin E1 Analog [EPC]"
        ],
        "pharm_class_cs": [
          "Prostaglandins E, Synthetic [CS]"
        ],
        "unii": [
          "0E43V0BB57",
          "QTG126297Q"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "TABLET, DELAYED RELEASE",
      "spl_id": "542fd9dd-a6d3-4432-9e7a-2ca5bce12956",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20210715",
      "product_id": "75834-264_542fd9dd-a6d3-4432-9e7a-2ca5bce12956",
      "application_number": "ANDA205143",
      "brand_name_base": "Diclofenac Sodium Misoprostol",
      "pharm_class": [
        "Anti-Inflammatory Agents",
        "Non-Steroidal [CS]",
        "Cyclooxygenase Inhibitors [MoA]",
        "Decreased Prostaglandin Production [PE]",
        "Nonsteroidal Anti-inflammatory Drug [EPC]",
        "Prostaglandin E1 Analog [EPC]",
        "Prostaglandins E",
        "Synthetic [CS]"
      ]
    }
  ]
}