{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "QUABIC-100 Hemodialysis Grade Sodium Bicarbonate Solution WATER SODIUM BICARBONATE BICARBONATE ION"
      ],
      "spl_unclassified_section": [
        "This is a Hemodialysis-Grade Sodium Bicarbonate Solutio. This solution already diluted 1.27:57 with purified wather (standard 13959:2014), provides: Sodium: 35..0 mEq/l Each 1000 mL of this solution contains: Sodium bicarbonate USP, hemodialysis grade: 84.0 g Purified water (standard iso 13959:2014), csp: 1000 mL"
      ],
      "active_ingredient": [
        "Sodium Bicarbonate: Antiseptic"
      ],
      "purpose": [
        "For use only with 3-pump hemodialysis machines."
      ],
      "indications_and_usage": [
        "",
        "Use only with 3-pump hemodialysis machines, together with acid concentrate for hemodialysis, diluting with purified water (standar ISO 13959:2014) IN A RATIO 1:1."
      ],
      "warnings": [
        "This solution should be transparent and colorless. Do not use if cloudy or with broken seal. If not all of the contents are used, discard the excess. Keep at room temperature."
      ],
      "dosage_and_administration": [
        "For use only with 3-pump hemodialysis machines, together with acid concentrate for hemodialysis, diluting with purified water."
      ],
      "do_not_use": [
        "If cloudy or with broken seal."
      ],
      "when_using": [
        "If not all the contents are used, discard the excess."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "storage_and_handling": [
        "Keep at room temperature."
      ],
      "inactive_ingredient": [
        "Purified water (standard ISO 13959:2014)"
      ],
      "package_label_principal_display_panel": [
        "NDC: 81943-503-02 QUABIC-100 LABEL"
      ],
      "set_id": "1484a825-40c6-a9c9-e063-6294a90a9ca4",
      "id": "434867f7-9e51-1f4e-e063-6394a90a641d",
      "effective_time": "20251110",
      "version": "2",
      "openfda": {
        "brand_name": [
          "QUABIC-100"
        ],
        "generic_name": [
          "HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION"
        ],
        "manufacturer_name": [
          "Aqua Medica, S.A. de C.V."
        ],
        "product_ndc": [
          "81943-503"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "HEMODIALYSIS"
        ],
        "substance_name": [
          "SODIUM BICARBONATE"
        ],
        "spl_id": [
          "434867f7-9e51-1f4e-e063-6394a90a641d"
        ],
        "spl_set_id": [
          "1484a825-40c6-a9c9-e063-6294a90a9ca4"
        ],
        "package_ndc": [
          "81943-503-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8MDF5V39QO"
        ]
      }
    }
  ]
}