{
  "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": "75854-313",
      "generic_name": "ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, levomefolate calcium, cyanocobalamin, biotin, calcium formate, ferrous asparto glycinate, potassium iodide, magnesium oxide, doconexent and icosapent",
      "labeler_name": "Avion Pharmaceuticals, LLC",
      "brand_name": "Prenate Essential",
      "active_ingredients": [
        {
          "name": "ICOSAPENT",
          "strength": "40 mg/1"
        },
        {
          "name": "ASCORBIC ACID",
          "strength": "90 mg/1"
        },
        {
          "name": "CHOLECALCIFEROL",
          "strength": "5.5 ug/1"
        },
        {
          "name": ".ALPHA.-TOCOPHEROL ACETATE, DL-",
          "strength": "4.5 mg/1"
        },
        {
          "name": "PYRIDOXINE HYDROCHLORIDE",
          "strength": "26 mg/1"
        },
        {
          "name": "FOLIC ACID",
          "strength": "400 ug/1"
        },
        {
          "name": "LEVOMEFOLATE CALCIUM",
          "strength": "600 ug/1"
        },
        {
          "name": "CYANOCOBALAMIN",
          "strength": "13 ug/1"
        },
        {
          "name": "BIOTIN",
          "strength": "280 ug/1"
        },
        {
          "name": "CALCIUM FORMATE",
          "strength": "160 mg/1"
        },
        {
          "name": "FERROUS ASPARTO GLYCINATE",
          "strength": "18 mg/1"
        },
        {
          "name": "POTASSIUM IODIDE",
          "strength": "150 ug/1"
        },
        {
          "name": "MAGNESIUM OXIDE",
          "strength": "50 mg/1"
        },
        {
          "name": "DOCONEXENT",
          "strength": "300 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "75854-313-30",
          "description": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-313-30)",
          "marketing_start_date": "20140718",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Avion Pharmaceuticals, LLC"
        ],
        "spl_set_id": [
          "e5acfb2a-0959-4542-9b4c-790be194d581"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000193618",
          "M0001797",
          "M0022797",
          "N0000175952",
          "M0022794",
          "N0000175951"
        ],
        "pharm_class_epc": [
          "Vitamin C [EPC]",
          "Vitamin D [EPC]",
          "Vitamin B12 [EPC]"
        ],
        "pharm_class_cs": [
          "Ascorbic Acid [CS]",
          "Vitamin D [CS]",
          "Vitamin B 12 [CS]"
        ],
        "unii": [
          "AAN7QOV9EA",
          "PQ6CK8PD0R",
          "1C6V77QF41",
          "WR1WPI7EW8",
          "68Y4CF58BV",
          "935E97BOY8",
          "A9R10K3F2F",
          "P6YC3EG204",
          "6SO6U10H04",
          "NP3JD65NPY",
          "H7426RGB3L",
          "1C4QK22F9J",
          "3A3U0GI71G",
          "ZAD9OKH9JC"
        ]
      },
      "marketing_category": "UNAPPROVED DRUG OTHER",
      "dosage_form": "CAPSULE, GELATIN COATED",
      "spl_id": "5413d54f-f790-2d5c-e063-6294a90a7460",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20140718",
      "product_id": "75854-313_5413d54f-f790-2d5c-e063-6294a90a7460",
      "brand_name_base": "Prenate Essential",
      "pharm_class": [
        "Analogs/Derivatives [Chemical/Ingredient]",
        "Ascorbic Acid [CS]",
        "Blood Coagulation Factor [EPC]",
        "Calcium [CS]",
        "Calculi Dissolution Agent [EPC]",
        "Cations",
        "Divalent [CS]",
        "Folate Analog [EPC]",
        "Folic Acid [CS]",
        "Increased Coagulation Factor Activity [PE]",
        "Increased Large Intestinal Motility [PE]",
        "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]",
        "Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]",
        "Magnesium Ion Exchange Activity [MoA]",
        "Osmotic Activity [MoA]",
        "Osmotic Laxative [EPC]",
        "Phosphate Binder [EPC]",
        "Phosphate Chelating Activity [MoA]",
        "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
        "Vitamin B 12 [CS]",
        "Vitamin B 6 [Chemical/Ingredient]",
        "Vitamin B12 [EPC]",
        "Vitamin B6 Analog [EPC]",
        "Vitamin C [EPC]",
        "Vitamin D [CS]",
        "Vitamin D [EPC]"
      ]
    }
  ]
}