{
  "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": "2026-10-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "49230-212",
      "generic_name": "Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
      "labeler_name": "Fresenius Medical Care Renal Therapies Group, LLC",
      "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": "49230-212-30",
          "description": "4 BAG in 1 CARTON (49230-212-30)  / 3000 mL in 1 BAG",
          "marketing_start_date": "19920819",
          "sample": false
        },
        {
          "package_ndc": "49230-212-32",
          "description": "4 BAG in 1 CARTON (49230-212-32)  / 3000 mL in 1 BAG",
          "marketing_start_date": "19920819",
          "sample": false
        },
        {
          "package_ndc": "49230-212-50",
          "description": "2 BAG in 1 CARTON (49230-212-50)  / 5000 mL in 1 BAG",
          "marketing_start_date": "19920819",
          "sample": false
        },
        {
          "package_ndc": "49230-212-52",
          "description": "2 BAG in 1 CARTON (49230-212-52)  / 5000 mL in 1 BAG",
          "marketing_start_date": "19920819",
          "sample": false
        },
        {
          "package_ndc": "49230-212-62",
          "description": "2 BAG in 1 CARTON (49230-212-62)  / 6000 mL in 1 BAG",
          "marketing_start_date": "19920819",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Fresenius Medical Care Renal Therapies Group, LLC"
        ],
        "spl_set_id": [
          "bbc5b820-4973-11e2-a192-0002a5d5c51b"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "451W47IQ8X",
          "TU7HW0W0QT",
          "02F3473H9O",
          "M4I0D6VV5M",
          "LX22YL083G"
        ]
      },
      "marketing_category": "NDA",
      "dosage_form": "SOLUTION",
      "spl_id": "5957678e-88ed-3325-e063-6294a90ac5d5",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "INTRAPERITONEAL"
      ],
      "marketing_start_date": "19920819",
      "product_id": "49230-212_5957678e-88ed-3325-e063-6294a90ac5d5",
      "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]"
      ]
    }
  ]
}