{
  "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": "2026-10-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "81153-100",
      "generic_name": "sulopenem etzadroxil and probenecid",
      "labeler_name": "ITERUM THERAPEUTICS US LIMITED",
      "brand_name": "ORLYNVAH",
      "active_ingredients": [
        {
          "name": "SULOPENEM ETZADROXIL",
          "strength": "500 mg/1"
        },
        {
          "name": "PROBENECID",
          "strength": "500 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "81153-100-01",
          "description": "1 BOTTLE in 1 CARTON (81153-100-01)  / 10 TABLET, FILM COATED in 1 BOTTLE",
          "marketing_start_date": "20250701",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "ITERUM THERAPEUTICS US LIMITED"
        ],
        "rxcui": [
          "2717843",
          "2717850"
        ],
        "spl_set_id": [
          "24c451c0-4cfb-37f3-e063-6394a90a895e"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "492M3I304T",
          "PO572Z7917"
        ]
      },
      "marketing_category": "NDA",
      "dosage_form": "TABLET, FILM COATED",
      "spl_id": "abcb22dd-7c10-4459-a98c-d03582b426a3",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20250701",
      "product_id": "81153-100_abcb22dd-7c10-4459-a98c-d03582b426a3",
      "application_number": "NDA213972",
      "brand_name_base": "ORLYNVAH"
    }
  ]
}