{
  "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": "2026-10-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "product_ndc": "72626-2601",
      "generic_name": "Ledipasvir and Sofosbuvir",
      "labeler_name": "Asegua Therapeutics LLC",
      "brand_name": "Ledipasvir and Sofosbuvir",
      "active_ingredients": [
        {
          "name": "LEDIPASVIR",
          "strength": "90 mg/1"
        },
        {
          "name": "SOFOSBUVIR",
          "strength": "400 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "72626-2601-1",
          "description": "2 BLISTER PACK in 1 CARTON (72626-2601-1)  / 14 TABLET, FILM COATED in 1 BLISTER PACK",
          "marketing_start_date": "20190101",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "Asegua Therapeutics LLC"
        ],
        "rxcui": [
          "1591943"
        ],
        "spl_set_id": [
          "46f4a73b-0cd6-4902-9092-3ac79e882c1a"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000191256",
          "N0000185503",
          "N0000190113",
          "N0000191493",
          "N0000191258"
        ],
        "pharm_class_epc": [
          "Hepatitis C Virus NS5A Inhibitor [EPC]",
          "Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "P-Glycoprotein Inhibitors [MoA]",
          "Breast Cancer Resistance Protein Inhibitors [MoA]",
          "RNA Replicase Inhibitors [MoA]"
        ],
        "unii": [
          "013TE6E4WV",
          "WJ6CA3ZU8B"
        ]
      },
      "marketing_category": "NDA AUTHORIZED GENERIC",
      "dosage_form": "TABLET, FILM COATED",
      "spl_id": "bd8387fe-8338-4241-b084-aec76726f8a9",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20190101",
      "product_id": "72626-2601_bd8387fe-8338-4241-b084-aec76726f8a9",
      "application_number": "NDA205834",
      "brand_name_base": "Ledipasvir and Sofosbuvir",
      "pharm_class": [
        "Breast Cancer Resistance Protein Inhibitors [MoA]",
        "Hepatitis C Virus NS5A Inhibitor [EPC]",
        "Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]",
        "P-Glycoprotein Inhibitors [MoA]",
        "RNA Replicase Inhibitors [MoA]"
      ]
    }
  ]
}