{
  "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": "2026-10-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "43386-050",
      "generic_name": "polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate",
      "labeler_name": "Lupin Pharmaceuticals,Inc.",
      "brand_name": "GAVILYTE-N",
      "active_ingredients": [
        {
          "name": "POLYETHYLENE GLYCOL 3350",
          "strength": "420 g/438.4g"
        },
        {
          "name": "SODIUM CHLORIDE",
          "strength": "11.2 g/438.4g"
        },
        {
          "name": "SODIUM BICARBONATE",
          "strength": "5.72 g/438.4g"
        },
        {
          "name": "POTASSIUM CHLORIDE",
          "strength": "1.48 g/438.4g"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "43386-050-19",
          "description": "438.4 g in 1 BOTTLE (43386-050-19)",
          "marketing_start_date": "20090528",
          "sample": true
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Lupin Pharmaceuticals,Inc."
        ],
        "rxcui": [
          "801054",
          "979099"
        ],
        "spl_set_id": [
          "27195187-75a3-431f-90d9-84da1b94e849"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000010288",
          "N0000175811",
          "N0000009871"
        ],
        "pharm_class_moa": [
          "Osmotic Activity [MoA]"
        ],
        "pharm_class_epc": [
          "Osmotic Laxative [EPC]"
        ],
        "pharm_class_pe": [
          "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"
        ],
        "unii": [
          "G2M7P15E5P",
          "451W47IQ8X",
          "8MDF5V39QO",
          "660YQ98I10"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "POWDER, FOR SOLUTION",
      "spl_id": "3839c7fd-e7c4-45c6-ae02-0302b40046b0",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20090528",
      "product_id": "43386-050_3839c7fd-e7c4-45c6-ae02-0302b40046b0",
      "application_number": "ANDA090019",
      "brand_name_base": "GAVILYTE-N",
      "pharm_class": [
        "Increased Large Intestinal Motility [PE]",
        "Increased Large Intestinal Motility [PE]",
        "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]",
        "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]",
        "Osmotic Activity [MoA]",
        "Osmotic Activity [MoA]",
        "Osmotic Activity [MoA]",
        "Osmotic Laxative [EPC]",
        "Osmotic Laxative [EPC]",
        "Osmotic Laxative [EPC]",
        "Potassium Compounds [CS]",
        "Potassium Salt [EPC]",
        "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"
      ]
    }
  ]
}