{
  "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": "2026-07-30",
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              "unii": [
                "9044SC542W"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "XOPENEX",
            "drugstructuredosagenumb": "3",
            "drugstructuredosageunit": "012",
            "drugdosagetext": "3 ML, QID",
            "drugadministrationroute": "055",
            "drugindication": "WHEEZING",
            "drugstartdateformat": "102",
            "drugstartdate": "20161102",
            "drugrecurreadministration": "3",
            "activesubstance": {
              "activesubstancename": "LEVALBUTEROL HYDROCHLORIDE"
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "MULTIVITAMIN",
            "drugstructuredosagenumb": "1",
            "drugstructuredosageunit": "032",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "12",
            "drugintervaldosagedefinition": "805",
            "drugdosagetext": "1 DF, BID",
            "drugadministrationroute": "048",
            "drugstartdateformat": "102",
            "drugstartdate": "20161220",
            "drugrecurreadministration": "3",
            "activesubstance": {
              "activesubstancename": "VITAMINS"
            },
            "openfda": {
              "brand_name": [
                "LUMAVEX",
                "PNV PRENATOL",
                "INFLAMEX",
                "AFLORA",
                "FOLIXIA",
                "NUTRALYN",
                "FOLCYTEINE",
                "VITALUX",
                "FOLYRA",
                "DAVIMET",
                "DAVIMET-M",
                "FOLATEN",
                "DEXATRAN",
                "FOLARTEX",
                "BOOSTERVITE",
                "MULTIVITAMIN",
                "LUNAVIRA",
                "PRENATOL-M"
              ],
              "generic_name": [
                "MULTIVITAMIN"
              ],
              "manufacturer_name": [
                "Oncora Pharma, LLC",
                "PureTek Corporation"
              ],
              "product_ndc": [
                "85477-610",
                "59088-078",
                "59088-191",
                "85477-904",
                "85477-902",
                "85477-903",
                "59088-795",
                "59088-139",
                "85477-523",
                "59088-695",
                "59088-158",
                "85477-901",
                "59088-643",
                "85477-511",
                "59088-022",
                "59088-018",
                "85477-623",
                "59088-009"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL",
                "CUTANEOUS"
              ],
              "substance_name": [
                "THIAMINE HYDROCHLORIDE",
                "NIACINAMIDE",
                "PYRIDOXINE HYDROCHLORIDE",
                "ASCORBIC ACID",
                "PANTOTHENIC ACID",
                "RIBOFLAVIN",
                "FOLIC ACID",
                "METHYLCOBALAMIN",
                "LEVOMEFOLATE CALCIUM",
                "CYANOCOBALAMIN",
                "CALCIUM CARBONATE",
                "VITAMIN A ACETATE",
                "THIAMINE MONONITRATE",
                "ZINC OXIDE",
                "MANGANESE SULFATE",
                ".ALPHA.-TOCOPHEROL ACETATE, DL-",
                "MAGNESIUM OXIDE",
                "CHROMIUM NICOTINATE",
                "MOLYBDENUM",
                "SELENIUM",
                "CHOLECALCIFEROL",
                "CHOLINE BITARTRATE",
                "FERROUS FUMARATE",
                "POTASSIUM IODIDE",
                "BLACK PEPPER",
                "GARLIC",
                "TURMERIC",
                "FERROUS BISGLYCINATE",
                "BETA CAROTENE",
                "BIOTIN",
                "CALCIUM CITRATE",
                "ACETYLCYSTEINE",
                "MAGNESIUM CITRATE",
                "LEVOMEFOLIC ACID",
                "VITAMIN A",
                "SODIUM ASCORBATE",
                "NIACIN",
                "MAGNESIUM SULFATE HEPTAHYDRATE",
                "CALCIUM PANTOTHENATE",
                "ZINC SULFATE",
                "CUPRIC SULFATE",
                "ORANGE JUICE",
                "BROCCOLI SPROUT",
                "PRUNUS CERASUS (BITTER CHERRY) FRUIT EXTRACT",
                "KALE",
                "WITHANIA SOMNIFERA ROOT"
              ],
              "spl_id": [
                "4139742d-d090-121c-e063-6394a90a6221",
                "583f00c7-1e74-9db6-e063-6294a90a684c",
                "1859a102-9152-018d-e063-6394a90a925f",
                "4aa3dbef-0e2d-49c7-e063-6294a90a9ba9",
                "4aa3e0fa-38cd-3f45-e063-6394a90a9a2b",
                "4aa3f835-f4aa-54bc-e063-6394a90ac250",
                "5592f382-e77e-a812-e063-6294a90a905c",
                "52d5fd35-3a68-5edd-e063-6394a90aba81",
                "d6bfe4ec-21dd-4b6c-8acf-2eda6d409d73",
                "22094f56-c791-2505-e063-6394a90ad0a4",
                "0b67e8de-d81d-0fda-e063-6394a90ac229",
                "4aa443c8-bb31-8f00-e063-6394a90a430d",
                "22078fec-3885-36f9-e063-6294a90aba17",
                "a9886a49-ba1d-44f5-96e5-26c927d6db9c",
                "53efb4bb-24d4-8c55-e063-6394a90ab7b7",
                "353453e2-1f60-24ea-e063-6394a90a251e",
                "474780d5-dd89-8f1a-e063-6294a90a03dc",
                "17559a44-94b8-9ca0-e063-6294a90a2123"
              ],
              "spl_set_id": [
                "4139742d-d091-121c-e063-6394a90a6221",
                "583f0194-0306-f31b-e063-6394a90a2a10",
                "1859a102-9152-018d-e063-6394a90a925f",
                "38e463d1-f608-7cb5-e063-6294a90a4abb",
                "413945b5-116b-d8b6-e063-6394a90a55e8",
                "33da017b-1e8c-d41c-e063-6394a90aab8c",
                "04cf0026-e29b-ffd5-e063-6294a90aca1f",
                "52d5eee7-8146-cc62-e063-6394a90a8c3f",
                "cb182e26-17c5-4d00-869f-08823afeeee8",
                "e4a57710-caa9-51e5-e053-2a95a90a8ad0",
                "0b67e8de-d81e-0fda-e063-6394a90ac229",
                "93086235-2c33-424d-b0c3-213031988581",
                "e052d2c2-7a3f-37be-e053-2a95a90af21c",
                "0a4cb0ab-565f-45e8-a989-740bccef21cd",
                "53efbf65-8844-8486-e063-6394a90a51d3",
                "353453e2-1f60-24ea-e063-6394a90a251e",
                "474780d5-dd88-8f1a-e063-6294a90a03dc",
                "17559a44-94b7-9ca0-e063-6294a90a2123"
              ],
              "package_ndc": [
                "85477-610-30",
                "59088-078-54",
                "59088-191-54",
                "85477-904-30",
                "85477-902-30",
                "85477-903-30",
                "59088-795-54",
                "59088-139-54",
                "85477-523-30",
                "59088-695-54",
                "59088-158-54",
                "85477-901-30",
                "59088-643-54",
                "85477-511-30",
                "59088-022-54",
                "59088-018-54",
                "85477-623-30",
                "59088-009-54"
              ],
              "nui": [
                "N0000193618",
                "M0001797",
                "M0022794",
                "N0000175951",
                "M0022797",
                "N0000175952",
                "N0000185371",
                "N0000175629",
                "N0000184306",
                "M0000728",
                "M0006342",
                "M0022575",
                "M0016962",
                "N0000175429",
                "N0000175961",
                "N0000008867",
                "N0000175960",
                "N0000175776",
                "N0000175547",
                "N0000178369",
                "M0008658",
                "M0022788",
                "N0000175950",
                "N0000175594",
                "M0014839"
              ],
              "pharm_class_epc": [
                "Vitamin C [EPC]",
                "Vitamin B12 [EPC]",
                "Vitamin D [EPC]",
                "Non-Standardized Food Allergenic Extract [EPC]",
                "Antidote [EPC]",
                "Antidote for Acetaminophen Overdose [EPC]",
                "Mucolytic [EPC]",
                "Folate Analog [EPC]",
                "Vitamin A [EPC]",
                "Nicotinic Acid [EPC]"
              ],
              "pharm_class_cs": [
                "Ascorbic Acid [CS]",
                "Vitamin B 12 [CS]",
                "Vitamin D [CS]",
                "Allergens [CS]",
                "Dietary Proteins [CS]",
                "Vegetable Proteins [CS]",
                "Plant Proteins [CS]",
                "Folic Acid [CS]",
                "Vitamin A [CS]",
                "Nicotinic Acids [CS]"
              ],
              "unii": [
                "M572600E5P",
                "25X51I8RD4",
                "68Y4CF58BV",
                "PQ6CK8PD0R",
                "19F5HK2737",
                "TLM2976OFR",
                "935E97BOY8",
                "BR1SN1JS2W",
                "A9R10K3F2F",
                "P6YC3EG204",
                "H0G9379FGK",
                "3LE3D9D6OY",
                "8K0I04919X",
                "SOI2LOH54Z",
                "W00LYS4T26",
                "WR1WPI7EW8",
                "3A3U0GI71G",
                "A150AY412V",
                "81AH48963U",
                "H6241UJ22B",
                "1C6V77QF41",
                "6K2W7T9V6Y",
                "R5L488RY0Q",
                "1C4QK22F9J",
                "KM66971LVF",
                "V1V998DC17",
                "856YO1Z64F",
                "SFW1D987QV",
                "01YAE03M7J",
                "6SO6U10H04",
                "MLM29U2X85",
                "WYQ7N0BPYC",
                "RHO26O1T9V",
                "8S95DH25XC",
                "81G40H8B0T",
                "S033EH8359",
                "2679MF687A",
                "SK47B8698T",
                "568ET80C3D",
                "89DS0H96TB",
                "LRX7AJ16DT",
                "5A9KE2L9L3",
                "128UH9LOAE",
                "1L29G6428X",
                "0Y3L4J38H1",
                "V038D626IF"
              ],
              "pharm_class_pe": [
                "Increased Histamine Release [PE]",
                "Cell-mediated Immunity [PE]",
                "Decreased Respiratory Secretion Viscosity [PE]",
                "Increased Glutathione Concentration [PE]"
              ],
              "pharm_class_moa": [
                "Reduction Activity [MoA]"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "PULMOZYME",
            "drugstructuredosagenumb": "2.5",
            "drugstructuredosageunit": "003",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "12",
            "drugintervaldosagedefinition": "805",
            "drugdosagetext": "2.5 MG, BID",
            "drugadministrationroute": "055",
            "drugstartdateformat": "102",
            "drugstartdate": "20161207",
            "drugrecurreadministration": "3",
            "activesubstance": {
              "activesubstancename": "DORNASE ALFA"
            },
            "openfda": {
              "application_number": [
                "BLA103532"
              ],
              "brand_name": [
                "PULMOZYME"
              ],
              "generic_name": [
                "DORNASE ALFA"
              ],
              "manufacturer_name": [
                "Genentech, Inc."
              ],
              "product_ndc": [
                "50242-100"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "RESPIRATORY (INHALATION)"
              ],
              "substance_name": [
                "DORNASE ALFA"
              ],
              "rxcui": [
                "205532",
                "310014"
              ],
              "spl_id": [
                "71192c41-f7be-44b0-b232-1f74369239a0"
              ],
              "spl_set_id": [
                "d8c78a7e-ff99-48f3-8952-643ec2ea0f86"
              ],
              "package_ndc": [
                "50242-100-39",
                "50242-100-40"
              ],
              "nui": [
                "N0000008867",
                "M0006007",
                "N0000175958",
                "M0018641"
              ],
              "pharm_class_pe": [
                "Decreased Respiratory Secretion Viscosity [PE]"
              ],
              "pharm_class_cs": [
                "Deoxyribonuclease I [CS]",
                "Recombinant Proteins [CS]"
              ],
              "pharm_class_epc": [
                "Recombinant Human Deoxyribonuclease 1 [EPC]"
              ],
              "unii": [
                "953A26OA1Y"
              ]
            }
          }
        ],
        "summary": {
          "narrativeincludeclinical": "CASE EVENT DATE: 201611"
        }
      }
    }
  ]
}