{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "METAVEX METAVEX CHOLECALCIFEROL CHOLECALCIFEROL FOLIC ACID FOLIC ACID BLUE AGAVE INULIN (AGAVE TEQUILANA) BLUE AGAVE INULIN (AGAVE TEQUILANA) ELM ELM ALOE FEROX LEAF ALOE FEROX LEAF RHAMNUS CATHARTICA BARK RHAMNUS CATHARTICA BARK STEARIC ACID CALCIUM CARBONATE CALCIUM PHOSPHATE MAGNESIUM STEARATE"
      ],
      "description": [
        "DESCRIPTION Metavex™ is a prescription folic acid–containing dietary supplement intended to support metabolic health. Each tablet contains a combination of vitamins, minerals, and botanical ingredients formulated to provide nutritional support."
      ],
      "indications_and_usage": [
        "INDICATIONS AND USAGE Metavex™ is indicated as a prescription dietary supplement for the dietary management of individuals with metabolic health needs where folic acid supplementation is appropriate. Administration: Take two (2) tablets daily with a 12-ounce glass of water, or as directed by a licensed healthcare practitioner."
      ],
      "contraindications": [
        "CONTRAINDICATIONS Metavex™ is contraindicated in patients with known hypersensitivity to any of its components."
      ],
      "warnings": [
        "WARNINGS Metavex™ should be administered under the supervision of a licensed medical practitioner. Patients should not exceed the recommended dosage. If adverse reactions occur, discontinue use and consult a healthcare professional."
      ],
      "precautions": [
        "Precautions Folic Acid and Vitamin B12 Deficiency: Folic acid administered alone may be inappropriate for the treatment of pernicious anemia or other megaloblastic anemias where vitamin B12 deficiency is present. Doses of folic acid greater than 0.1 mg daily may mask hematologic signs of pernicious anemia while neurological manifestations continue to progress. Patients with underlying medical conditions or those taking other medications should consult their healthcare provider prior to use."
      ],
      "dosage_and_administration": [
        "DOSAGE AND ADMINISTRATION Take two (2) tablets daily with a 12-ounce glass of water, or as directed by a licensed healthcare practitioner."
      ],
      "how_supplied": [
        "HOW SUPPLIED Metavex™ is supplied as tan, oval tablets in bottles of 30 tablets. NDC 85477-503-30"
      ],
      "package_label_principal_display_panel": [
        "Display Panel Metavex™ METABOLIC HEALTH Prescription Folic Acid-Containing Dietary Supplement 30 Tablets Dispensed by Prescription Distributed by: Oncora Pharma Dallas, TX 75228 NDC 85477-503-30 metavex pdp"
      ],
      "set_id": "1ec54297-9b2d-427f-afc9-b18f4f8ffd93",
      "id": "0733c82d-8d75-4f70-9744-71e526509b95",
      "effective_time": "20260106",
      "version": "2",
      "openfda": {
        "brand_name": [
          "METAVEX"
        ],
        "generic_name": [
          "METAVEX"
        ],
        "manufacturer_name": [
          "Oncora Pharma, LLC"
        ],
        "product_ndc": [
          "85477-503"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ALOE FEROX LEAF",
          "BLUE AGAVE INULIN (AGAVE TEQUILANA)",
          "CHOLECALCIFEROL",
          "ELM",
          "FOLIC ACID",
          "RHAMNUS CATHARTICA BARK"
        ],
        "spl_id": [
          "0733c82d-8d75-4f70-9744-71e526509b95"
        ],
        "spl_set_id": [
          "1ec54297-9b2d-427f-afc9-b18f4f8ffd93"
        ],
        "package_ndc": [
          "85477-503-30"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "M0022797",
          "N0000175952"
        ],
        "pharm_class_cs": [
          "Vitamin D [CS]"
        ],
        "pharm_class_epc": [
          "Vitamin D [EPC]"
        ],
        "unii": [
          "0D145J8EME",
          "PW973NF38H",
          "1C6V77QF41",
          "63POE2M46Y",
          "935E97BOY8",
          "KD27950XHY"
        ]
      }
    }
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}