{
  "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": "2026-09-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "46163-212",
      "generic_name": "dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride",
      "labeler_name": "Fresenius Medical Care de Mexico, S.A. de C.V.",
      "brand_name": "Delflex",
      "active_ingredients": [
        {
          "name": "DEXTROSE MONOHYDRATE",
          "strength": "4.25 g/100mL"
        },
        {
          "name": "SODIUM CHLORIDE",
          "strength": "538 mg/100mL"
        },
        {
          "name": "SODIUM LACTATE",
          "strength": "448 mg/100mL"
        },
        {
          "name": "CALCIUM CHLORIDE",
          "strength": "18.4 mg/100mL"
        },
        {
          "name": "MAGNESIUM CHLORIDE",
          "strength": "5.08 mg/100mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "46163-212-92",
          "description": "5 BAG in 1 CARTON (46163-212-92)  / 2000 mL in 1 BAG",
          "marketing_start_date": "20240829",
          "sample": false
        },
        {
          "package_ndc": "46163-212-94",
          "description": "5 BAG in 1 CARTON (46163-212-94)  / 2500 mL in 1 BAG",
          "marketing_start_date": "20240829",
          "sample": false
        },
        {
          "package_ndc": "46163-212-95",
          "description": "5 BAG in 1 CARTON (46163-212-95)  / 2000 mL in 1 BAG",
          "marketing_start_date": "20240829",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Fresenius Medical Care de Mexico, S.A. de C.V."
        ],
        "spl_set_id": [
          "a98facd6-9daa-4d37-8209-63a0599dbfaa"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "LX22YL083G",
          "02F3473H9O",
          "451W47IQ8X",
          "M4I0D6VV5M",
          "TU7HW0W0QT"
        ]
      },
      "marketing_category": "NDA",
      "dosage_form": "SOLUTION",
      "spl_id": "579dba0f-f820-8f9a-e063-6294a90a76b0",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "INTRAPERITONEAL"
      ],
      "marketing_start_date": "20240829",
      "product_id": "46163-212_579dba0f-f820-8f9a-e063-6294a90a76b0",
      "application_number": "NDA020171",
      "brand_name_base": "Delflex",
      "pharm_class": [
        "Blood Coagulation Factor [EPC]",
        "Calcium [CS]",
        "Calculi Dissolution Agent [EPC]",
        "Cations",
        "Divalent [CS]",
        "Increased Coagulation Factor Activity [PE]",
        "Increased Large Intestinal Motility [PE]",
        "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 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 Activity [MoA]",
        "Osmotic Laxative [EPC]",
        "Osmotic Laxative [EPC]",
        "Osmotic Laxative [EPC]",
        "Phosphate Binder [EPC]",
        "Phosphate Chelating Activity [MoA]",
        "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"
      ]
    }
  ]
}