{
  "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": "43386-700",
      "generic_name": "sodium sulfate, potassium sulfate, magnesium sulfate",
      "labeler_name": "Lupin Pharmaceuticals, Inc.",
      "brand_name": "SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE",
      "active_ingredients": [
        {
          "name": "SODIUM SULFATE",
          "strength": "17.5 g/177mL"
        },
        {
          "name": "POTASSIUM SULFATE",
          "strength": "3.13 g/177mL"
        },
        {
          "name": "MAGNESIUM SULFATE ANHYDROUS",
          "strength": "1.6 g/177mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "43386-700-83",
          "description": "2 BOTTLE in 1 CARTON (43386-700-83)  / 177 mL in 1 BOTTLE",
          "marketing_start_date": "20221230",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "rxcui": [
          "1001689",
          "1120068"
        ],
        "spl_set_id": [
          "d4883657-d27d-4056-a567-5fb12d5e05d1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "0YPR65R21J",
          "1K573LC5TV",
          "ML30MJ2U7I"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "SOLUTION",
      "spl_id": "9fffaef0-0578-452d-a365-166b183d8e00",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20221230",
      "product_id": "43386-700_9fffaef0-0578-452d-a365-166b183d8e00",
      "application_number": "ANDA202511",
      "brand_name_base": "SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE",
      "pharm_class": [
        "Calculi Dissolution Agent [EPC]",
        "Increased Large Intestinal Motility [PE]",
        "Increased Large Intestinal Motility [PE]",
        "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]",
        "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]",
        "Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]",
        "Magnesium Ion Exchange Activity [MoA]",
        "Osmotic Activity [MoA]",
        "Osmotic Activity [MoA]",
        "Osmotic Laxative [EPC]",
        "Osmotic Laxative [EPC]",
        "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"
      ]
    }
  ]
}