{
  "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": "2026-07-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 5
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Embriva ASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, PYRIDOXAL PHOSPHATE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE, POTASSIUM IODIDE PYRIDOXAL PHOSPHATE ANHYDROUS PYRIDOXAL PHOSPHATE ANHYDROUS POTASSIUM IODIDE IODIDE ION MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL THIAMINE THIAMINE ION FOLIC ACID FOLIC ACID METHYLCOBALAMIN METHYLCOBALAMIN CALCIUM CARBONATE CALCIUM CATION FERROUS GLUCONATE FERROUS CATION"
      ],
      "description": [
        "DESCRIPTION Each Tablet Contains: Amount per Tablet Thiamine (Vitamin B-1) (from Thiamine Mononitrate) ................. 1.4 mg Ascorbic Acid...................... ......................................................... 125 mg Folic Acid ....................................................................................... 1 mg Colecalciferol ............................................................................. .0125 mg Pyridoxal Phosphate Anhydrous ................................................. 2.5 mg Methylcobalamin.................. ........................................................ 1 mg Calcium Carbonate ................................................................... 200 mg Ferrous Gluconate ..................................................................... 13 mg Potassium Iodide........................................................................ .15 mg Other ingredients: magnesium stearate, microcrystalline cellulose, silicone dioxide"
      ],
      "indications_and_usage": [
        "INDICATIONS AND USAGE Prenatal and Postnatal prescriptive Folic Acid"
      ],
      "warnings": [
        "WARNINGS WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under age 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately."
      ],
      "warnings_table": [
        "<table><col/><tbody><tr><td styleCode=\" Botrule Toprule Lrule Rrule\"><content styleCode=\"bold\">WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under age 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately.</content><content styleCode=\"bold\"> </content></td></tr></tbody></table>"
      ],
      "precautions": [
        "PRECAUTIONS Call your licensed medical practitioner about side effects."
      ],
      "dosage_and_administration": [
        "DOSAGE AND ADMINISTRATION Usual adult dose is 1 tablet once or twice daily or as prescribed by a licensed practitioner."
      ],
      "how_supplied": [
        "HOW SUPPLIED Bottles of 30: 85477-0322-30 Storage KEEP THIS AND ALL MEDICATION OUR OF THE REACH OF CHILDREN."
      ],
      "storage_and_handling": [
        "Storage KEEP THIS AND ALL MEDICATION OUR OF THE REACH OF CHILDREN."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL label"
      ],
      "set_id": "3c362de4-1ed9-83be-e063-6394a90a10fc",
      "id": "3c362de4-1eda-83be-e063-6394a90a10fc",
      "effective_time": "20250812",
      "version": "1",
      "openfda": {
        "brand_name": [
          "Embriva"
        ],
        "generic_name": [
          "ASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, PYRIDOXAL PHOSPHATE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE, POTASSIUM IODIDE"
        ],
        "manufacturer_name": [
          "Oncora Pharma, LLC"
        ],
        "product_ndc": [
          "85477-322"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ASCORBIC ACID",
          "CALCIUM CARBONATE",
          "CHOLECALCIFEROL",
          "FERROUS GLUCONATE",
          "FOLIC ACID",
          "METHYLCOBALAMIN",
          "POTASSIUM IODIDE",
          "PYRIDOXAL PHOSPHATE ANHYDROUS",
          "THIAMINE"
        ],
        "spl_id": [
          "3c362de4-1eda-83be-e063-6394a90a10fc"
        ],
        "spl_set_id": [
          "3c362de4-1ed9-83be-e063-6394a90a10fc"
        ],
        "package_ndc": [
          "85477-322-30"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000193618",
          "M0001797",
          "M0022797",
          "N0000175952"
        ],
        "pharm_class_epc": [
          "Vitamin C [EPC]",
          "Vitamin D [EPC]"
        ],
        "pharm_class_cs": [
          "Ascorbic Acid [CS]",
          "Vitamin D [CS]"
        ],
        "unii": [
          "PQ6CK8PD0R",
          "H0G9379FGK",
          "1C6V77QF41",
          "U1B11I423Z",
          "935E97BOY8",
          "BR1SN1JS2W",
          "1C4QK22F9J",
          "F06SGE49M6",
          "X66NSO3N35"
        ]
      }
    }
  ]
}