{
  "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": "2026-06-01",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "ISOTONIC SODIUM CHLORIDE biofleks ISOTONIC SODIUM CHLORIDE STERILE SODIUM CHLORIDE CHLORIDE ION WATER"
      ],
      "general_precautions": [
        "ADMINISTERED INTRAVENOUSLY ASEPTICALLY. Do not use if the solution is not clear or the bag is damaged. Please read the package leaflet. Consult your doctor right away if you have any unexpected effect. It is disposable. Partially used solutions should not be stored. Keep out of reach and sight of the children and store in the original package. Store at room temperature below 25°C. Sold with prescription only."
      ],
      "package_label_principal_display_panel": [
        "biofleks 100 mL 0.9 % ISOTONIC SODIUM CHLORIDE SOLUTION STERILE Per 100 mL Sodium Chloride Water for Injection Electrolyte Concentrations (mEq/L) ADMINISTERED INTRAVENOUSLY ASEPTICALLY. Do not use if the solution is not clear or the bag is damaged. Please read the package leaflet. Consult your doctor right away if you have any unexpected effect. It is disposable. Partially used solutions should not be stored. Keep out of reach and sight of the children and store in the original package. Store at room temperature below 25°C. Sold with prescription only. Distributor: Vin Trading LLC Phone: (201) 676-3232 / E-Mail: info@vintradingllc.com Address: 203 Lemoine Ave #118, Fort Lee, NJ 07024 OSEL llaç San. ve Tic. A.Ş. Beykoz / İstanbul / TURKEY 100mL Bag 250mL Bag 500 mL Bag 1000mL Bag 100 mL 250 mL 500 mL 1000 mL"
      ],
      "set_id": "2be5b3e2-c4a4-00ea-e063-6394a90a6163",
      "id": "3467db24-ab2d-317e-e063-6294a90ab055",
      "effective_time": "20250505",
      "version": "4",
      "openfda": {
        "brand_name": [
          "ISOTONIC SODIUM CHLORIDE"
        ],
        "generic_name": [
          "BIOFLEKS ISOTONIC SODIUM CHLORIDE STERILE"
        ],
        "manufacturer_name": [
          "HAVER FARMA ILAC ANONIM SIRKETI"
        ],
        "product_ndc": [
          "85184-0001"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS",
          "IRRIGATION",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "SODIUM CHLORIDE"
        ],
        "rxcui": [
          "1807632",
          "1807633",
          "1807634",
          "1807639"
        ],
        "spl_id": [
          "3467db24-ab2d-317e-e063-6294a90ab055"
        ],
        "spl_set_id": [
          "2be5b3e2-c4a4-00ea-e063-6394a90a6163"
        ],
        "package_ndc": [
          "85184-0001-1",
          "85184-0001-2",
          "85184-0001-3",
          "85184-0001-4"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "451W47IQ8X"
        ]
      }
    }
  ]
}