{
  "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": "2026-04-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 48897
    }
  },
  "results": [
    {
      "safetyreportversion": "1",
      "safetyreportid": "10004351",
      "primarysourcecountry": "US",
      "occurcountry": "US",
      "transmissiondateformat": "102",
      "transmissiondate": "20141002",
      "reporttype": "1",
      "serious": "2",
      "receivedateformat": "102",
      "receivedate": "20140312",
      "receiptdateformat": "102",
      "receiptdate": "20140312",
      "fulfillexpeditecriteria": "2",
      "companynumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-09511BP",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "BOEHRINGER INGELHEIM",
        "duplicatenumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-09511BP"
      },
      "primarysource": {
        "reportercountry": "US",
        "qualification": "5"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientsex": "2",
        "reaction": [
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Hypoaesthesia",
            "reactionoutcome": "3"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Vision blurred",
            "reactionoutcome": "3"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "SPIRIVA",
            "drugauthorizationnumb": "021395",
            "drugstructuredosagenumb": "18",
            "drugstructuredosageunit": "004",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
            "drugdosagetext": "18 MCG",
            "drugdosageform": "INHALATION POWDER, HARD CAPSULE",
            "drugadministrationroute": "055",
            "drugindication": "CHRONIC OBSTRUCTIVE PULMONARY DISEASE",
            "drugstartdateformat": "602",
            "drugstartdate": "2005",
            "actiondrug": "4",
            "openfda": {
              "application_number": [
                "NDA021395"
              ],
              "brand_name": [
                "SPIRIVA HANDIHALER"
              ],
              "generic_name": [
                "TIOTROPIUM BROMIDE"
              ],
              "manufacturer_name": [
                "Boehringer Ingelheim Pharmaceuticals, Inc."
              ],
              "product_ndc": [
                "0597-0075"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL",
                "RESPIRATORY (INHALATION)"
              ],
              "substance_name": [
                "TIOTROPIUM BROMIDE MONOHYDRATE"
              ],
              "rxcui": [
                "485032",
                "580261"
              ],
              "spl_id": [
                "94768574-0d3e-46f0-9f75-ab3c9f52857d"
              ],
              "spl_set_id": [
                "820839ef-e53d-47e8-a3b9-d911ff92e6a9"
              ],
              "package_ndc": [
                "0597-0075-41",
                "0597-0075-75",
                "0597-0075-47"
              ],
              "unii": [
                "L64SXO195N"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "THEODUR",
            "drugadministrationroute": "048"
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "METFORMIN",
            "drugstructuredosagenumb": "500",
            "drugstructuredosageunit": "003",
            "drugseparatedosagenumb": "2",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
            "drugdosagetext": "1000 MG",
            "drugadministrationroute": "048",
            "openfda": {
              "application_number": [
                "ANDA200690",
                "ANDA209674",
                "ANDA209313"
              ],
              "brand_name": [
                "METFORMIN HYDROCHLORIDE",
                "METFORMIN"
              ],
              "generic_name": [
                "METFORMIN",
                "METFORMIN ER 500 MG",
                "METFORMIN ER 750 MG"
              ],
              "manufacturer_name": [
                "Mylan Pharmaceuticals Inc.",
                "Ingenus Pharmaceuticals, LLC",
                "Granules Pharmaceuticals Inc."
              ],
              "product_ndc": [
                "0378-6001",
                "0378-6002",
                "50742-633",
                "50742-634",
                "70010-491",
                "70010-492"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "METFORMIN HYDROCHLORIDE"
              ],
              "rxcui": [
                "1807894",
                "1807917",
                "860975",
                "860981"
              ],
              "spl_id": [
                "7c8e06cd-8ef3-4a03-b4ee-3df6899280cf",
                "3a97a225-ff03-4d81-a2fe-7f66611cc4c1",
                "451bc376-d523-ee84-e063-6394a90a4743"
              ],
              "spl_set_id": [
                "7e41818c-60e9-4bcf-9586-7bb8d33d5e89",
                "49a0b5c2-ebaf-4c4c-905f-dfd1962ac647",
                "6d6ee6f8-9650-ff4f-e053-2991aa0acf19"
              ],
              "package_ndc": [
                "0378-6002-91",
                "0378-6001-91",
                "50742-633-60",
                "50742-633-90",
                "50742-633-10",
                "50742-634-30",
                "50742-634-60",
                "50742-634-10",
                "70010-491-01",
                "70010-491-05",
                "70010-491-10",
                "70010-491-18",
                "70010-491-19",
                "70010-491-09",
                "70010-492-01",
                "70010-492-05",
                "70010-492-20",
                "70010-492-21"
              ],
              "unii": [
                "786Z46389E"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "LOTENSIN",
            "drugstructuredosagenumb": "10",
            "drugstructuredosageunit": "003",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
            "drugdosagetext": "10 MG",
            "drugadministrationroute": "048",
            "openfda": {
              "application_number": [
                "NDA019851"
              ],
              "brand_name": [
                "LOTENSIN"
              ],
              "generic_name": [
                "BENAZEPRIL HYDROCHLORIDE"
              ],
              "manufacturer_name": [
                "Validus Pharmaceuticals LLC"
              ],
              "product_ndc": [
                "30698-448",
                "30698-449",
                "30698-450"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "BENAZEPRIL HYDROCHLORIDE"
              ],
              "rxcui": [
                "898687",
                "898689",
                "898690",
                "898692",
                "898719",
                "898721"
              ],
              "spl_id": [
                "40029d07-adfa-0cc3-e063-6294a90a4cd5"
              ],
              "spl_set_id": [
                "2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e"
              ],
              "package_ndc": [
                "30698-449-01",
                "30698-450-01",
                "30698-448-01"
              ],
              "unii": [
                "N1SN99T69T"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "COREG",
            "drugstructuredosagenumb": "1.5",
            "drugstructuredosageunit": "003",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
            "drugdosagetext": "1.5 MG",
            "drugadministrationroute": "048",
            "openfda": {
              "application_number": [
                "NDA020297"
              ],
              "brand_name": [
                "COREG"
              ],
              "generic_name": [
                "CARVEDILOL"
              ],
              "manufacturer_name": [
                "Waylis Therapeutics LLC"
              ],
              "product_ndc": [
                "80725-139",
                "80725-140",
                "80725-141",
                "80725-142"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "CARVEDILOL"
              ],
              "rxcui": [
                "200031",
                "200032",
                "200033",
                "212388",
                "212389",
                "212390",
                "686924",
                "686926"
              ],
              "spl_id": [
                "f2798247-00df-4ec2-a6f8-1902f10b5558"
              ],
              "spl_set_id": [
                "07c619c6-4a0c-445e-94fa-664a54f68a39"
              ],
              "package_ndc": [
                "80725-139-20",
                "80725-140-20",
                "80725-141-20",
                "80725-142-20"
              ],
              "nui": [
                "N0000000099",
                "N0000009923",
                "N0000009924",
                "N0000175553",
                "N0000175556"
              ],
              "pharm_class_moa": [
                "Adrenergic alpha-Antagonists [MoA]",
                "Adrenergic beta1-Antagonists [MoA]",
                "Adrenergic beta2-Antagonists [MoA]"
              ],
              "pharm_class_epc": [
                "alpha-Adrenergic Blocker [EPC]",
                "beta-Adrenergic Blocker [EPC]"
              ],
              "unii": [
                "0K47UL67F2"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "PROTONIX",
            "drugstructuredosagenumb": "40",
            "drugstructuredosageunit": "003",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
            "drugdosagetext": "40 MG",
            "drugadministrationroute": "048",
            "openfda": {
              "application_number": [
                "NDA020988",
                "NDA020987",
                "NDA022020"
              ],
              "brand_name": [
                "PROTONIX I.V.",
                "PROTONIX DELAYED-RELEASE"
              ],
              "generic_name": [
                "PANTOPRAZOLE SODIUM"
              ],
              "manufacturer_name": [
                "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc."
              ],
              "product_ndc": [
                "0008-0923",
                "0008-4001",
                "0008-0841",
                "0008-0843",
                "0008-0844"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "INTRAVENOUS",
                "ORAL"
              ],
              "substance_name": [
                "PANTOPRAZOLE SODIUM"
              ],
              "rxcui": [
                "283669",
                "885257"
              ],
              "spl_id": [
                "a7e7d657-a748-4234-8dd6-c0e4d0f81a86",
                "d36cd2fb-517f-44e5-8438-53e563775f86",
                "b1adaee5-9353-48ce-bde4-f169a3787e30"
              ],
              "spl_set_id": [
                "51e4144a-489e-436c-609a-39305f8f56ba",
                "f39b3e7d-39d2-4c8a-9974-4ab885241880",
                "08098cb2-c048-4640-f387-6beec4a38936"
              ],
              "package_ndc": [
                "0008-0923-51",
                "0008-0923-60",
                "0008-0923-55",
                "0008-4001-01",
                "0008-4001-10",
                "0008-4001-25",
                "0008-0843-81",
                "0008-0841-81",
                "0008-0844-01",
                "0008-0844-02"
              ],
              "unii": [
                "6871619Q5X"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "FERROUS SULFATE",
            "drugadministrationroute": "048",
            "openfda": {
              "brand_name": [
                "FERRUM SULPHURICUM",
                "FERROUS SULFATE"
              ],
              "generic_name": [
                "FERROUS SULFATE"
              ],
              "manufacturer_name": [
                "Boiron",
                "Richmond Pharmaceuticals, Inc.",
                "Richmond Pharmaceuticals Inc."
              ],
              "product_ndc": [
                "0220-2113",
                "54738-963",
                "0220-2111"
              ],
              "product_type": [
                "HUMAN OTC DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "FERROUS SULFATE"
              ],
              "spl_id": [
                "3a749d62-0e21-0c15-e063-6394a90ac1a8",
                "2a327c66-d561-6a9b-e063-6294a90a5d0a",
                "0a0cbae3-25d2-6d47-e063-6294a90a0431",
                "2a327df7-e75d-8130-e063-6294a90a6e83"
              ],
              "spl_set_id": [
                "3a749d62-0e20-0c15-e063-6394a90ac1a8",
                "58dd4f30-980b-44bc-9f8e-8d4626854b91",
                "7a4087d8-d054-bbdc-e053-2991aa0ae8cf",
                "5514d582-19b5-4f1e-b794-f790afb8211c"
              ],
              "package_ndc": [
                "0220-2113-41",
                "54738-963-01",
                "54738-963-03",
                "0220-2111-41",
                "54738-963-13"
              ],
              "unii": [
                "39R4TAN1VT"
              ],
              "rxcui": [
                "310325"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "ZOCOR",
            "drugstructuredosagenumb": "40",
            "drugstructuredosageunit": "003",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
            "drugdosagetext": "40 MG",
            "drugadministrationroute": "048",
            "openfda": {
              "application_number": [
                "NDA019766"
              ],
              "brand_name": [
                "ZOCOR"
              ],
              "generic_name": [
                "SIMVASTATIN"
              ],
              "manufacturer_name": [
                "Organon LLC"
              ],
              "product_ndc": [
                "78206-180",
                "78206-182",
                "78206-181"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "SIMVASTATIN"
              ],
              "rxcui": [
                "104490",
                "104491",
                "152923",
                "198211",
                "312961",
                "314231"
              ],
              "spl_id": [
                "11256523-425c-48e8-afe1-e3a4e28c892e"
              ],
              "spl_set_id": [
                "8f55d5de-5a4f-4a39-8c84-c53976dd6af9"
              ],
              "package_ndc": [
                "78206-182-01",
                "78206-182-02",
                "78206-181-02",
                "78206-181-01",
                "78206-180-01",
                "78206-180-02"
              ],
              "nui": [
                "N0000175589",
                "N0000000121"
              ],
              "pharm_class_epc": [
                "HMG-CoA Reductase Inhibitor [EPC]"
              ],
              "pharm_class_moa": [
                "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"
              ],
              "unii": [
                "AGG2FN16EV"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "MULTIVITAMIN",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
            "drugadministrationroute": "048",
            "openfda": {
              "brand_name": [
                "LUMAVEX",
                "INFLAMEX",
                "AFLORA",
                "FOLIXIA",
                "NUTRALYN",
                "FOLCYTEINE",
                "FOLYRA",
                "DAVIMET",
                "DAVIMET-M",
                "LIQUICAL PLUS",
                "FOLATEN",
                "DEXATRAN",
                "FOLARTEX",
                "MULTIVITAMIN",
                "LUNAVIRA",
                "PRENATOL-M"
              ],
              "generic_name": [
                "MULTIVITAMIN"
              ],
              "manufacturer_name": [
                "Oncora Pharma, LLC",
                "PureTek Corporation"
              ],
              "product_ndc": [
                "85477-610",
                "59088-191",
                "85477-904",
                "85477-902",
                "85477-903",
                "59088-795",
                "85477-523",
                "59088-695",
                "59088-158",
                "59088-201",
                "85477-901",
                "59088-643",
                "85477-511",
                "59088-018",
                "85477-623",
                "59088-009"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL",
                "CUTANEOUS"
              ],
              "substance_name": [
                "ASCORBIC ACID",
                "FOLIC ACID",
                "METHYLCOBALAMIN",
                "NIACINAMIDE",
                "PANTOTHENIC ACID",
                "PYRIDOXINE HYDROCHLORIDE",
                "RIBOFLAVIN",
                "THIAMINE HYDROCHLORIDE",
                "BLACK PEPPER",
                "GARLIC",
                "LEVOMEFOLATE CALCIUM",
                "TURMERIC",
                ".ALPHA.-TOCOPHEROL ACETATE, DL-",
                "BETA CAROTENE",
                "BIOTIN",
                "CALCIUM CARBONATE",
                "CHOLECALCIFEROL",
                "CYANOCOBALAMIN",
                "FERROUS BISGLYCINATE",
                "MAGNESIUM OXIDE",
                "POTASSIUM IODIDE",
                "ACETYLCYSTEINE",
                "CALCIUM CITRATE",
                "MAGNESIUM CITRATE",
                "NIACIN",
                "SODIUM ASCORBATE",
                "THIAMINE MONONITRATE",
                "VITAMIN A",
                "ZINC CITRATE",
                "CALCIUM PANTOTHENATE",
                "CUPRIC SULFATE",
                "FERROUS FUMARATE",
                "MAGNESIUM SULFATE HEPTAHYDRATE",
                "MANGANESE SULFATE",
                "ZINC SULFATE",
                "CHOLINE BITARTRATE",
                "CHROMIUM NICOTINATE",
                "MOLYBDENUM",
                "SELENIUM",
                "VITAMIN A ACETATE",
                "ZINC OXIDE"
              ],
              "spl_id": [
                "4139742d-d090-121c-e063-6394a90a6221",
                "1859a102-9152-018d-e063-6394a90a925f",
                "4aa3dbef-0e2d-49c7-e063-6294a90a9ba9",
                "4aa3e0fa-38cd-3f45-e063-6394a90a9a2b",
                "4aa3f835-f4aa-54bc-e063-6394a90ac250",
                "04cf0026-e299-ffd5-e063-6294a90aca1f",
                "d6bfe4ec-21dd-4b6c-8acf-2eda6d409d73",
                "22094f56-c791-2505-e063-6394a90ad0a4",
                "0b67e8de-d81d-0fda-e063-6394a90ac229",
                "21b7a39d-8d50-3f46-e063-6394a90a6404",
                "4aa443c8-bb31-8f00-e063-6394a90a430d",
                "22078fec-3885-36f9-e063-6294a90aba17",
                "a9886a49-ba1d-44f5-96e5-26c927d6db9c",
                "353453e2-1f60-24ea-e063-6394a90a251e",
                "474780d5-dd89-8f1a-e063-6294a90a03dc",
                "17559a44-94b8-9ca0-e063-6294a90a2123"
              ],
              "spl_set_id": [
                "4139742d-d091-121c-e063-6394a90a6221",
                "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",
                "cb182e26-17c5-4d00-869f-08823afeeee8",
                "e4a57710-caa9-51e5-e053-2a95a90a8ad0",
                "0b67e8de-d81e-0fda-e063-6394a90ac229",
                "1ab92efb-ae5a-b71c-e063-6294a90a60d1",
                "93086235-2c33-424d-b0c3-213031988581",
                "e052d2c2-7a3f-37be-e053-2a95a90af21c",
                "0a4cb0ab-565f-45e8-a989-740bccef21cd",
                "353453e2-1f60-24ea-e063-6394a90a251e",
                "474780d5-dd88-8f1a-e063-6294a90a03dc",
                "17559a44-94b7-9ca0-e063-6294a90a2123"
              ],
              "package_ndc": [
                "85477-610-30",
                "59088-191-54",
                "85477-904-30",
                "85477-902-30",
                "85477-903-30",
                "59088-795-54",
                "85477-523-30",
                "59088-695-54",
                "59088-158-54",
                "59088-201-31",
                "85477-901-30",
                "59088-643-54",
                "85477-511-30",
                "59088-018-54",
                "85477-623-30",
                "59088-009-54"
              ],
              "nui": [
                "N0000193618",
                "M0001797",
                "N0000185371",
                "N0000175629",
                "N0000184306",
                "M0000728",
                "M0006342",
                "M0022575",
                "M0016962",
                "M0022797",
                "N0000175952",
                "M0022794",
                "N0000175951",
                "N0000175429",
                "N0000175961",
                "N0000008867",
                "N0000175960",
                "N0000175776",
                "N0000175547",
                "N0000175594",
                "M0014839",
                "M0022788",
                "N0000175950"
              ],
              "pharm_class_epc": [
                "Vitamin C [EPC]",
                "Non-Standardized Food Allergenic Extract [EPC]",
                "Vitamin D [EPC]",
                "Vitamin B12 [EPC]",
                "Antidote [EPC]",
                "Antidote for Acetaminophen Overdose [EPC]",
                "Mucolytic [EPC]",
                "Nicotinic Acid [EPC]",
                "Vitamin A [EPC]"
              ],
              "pharm_class_cs": [
                "Ascorbic Acid [CS]",
                "Allergens [CS]",
                "Dietary Proteins [CS]",
                "Vegetable Proteins [CS]",
                "Plant Proteins [CS]",
                "Vitamin D [CS]",
                "Vitamin B 12 [CS]",
                "Nicotinic Acids [CS]",
                "Vitamin A [CS]"
              ],
              "unii": [
                "PQ6CK8PD0R",
                "935E97BOY8",
                "BR1SN1JS2W",
                "25X51I8RD4",
                "19F5HK2737",
                "68Y4CF58BV",
                "TLM2976OFR",
                "M572600E5P",
                "KM66971LVF",
                "V1V998DC17",
                "A9R10K3F2F",
                "856YO1Z64F",
                "WR1WPI7EW8",
                "01YAE03M7J",
                "6SO6U10H04",
                "H0G9379FGK",
                "1C6V77QF41",
                "P6YC3EG204",
                "SFW1D987QV",
                "3A3U0GI71G",
                "1C4QK22F9J",
                "WYQ7N0BPYC",
                "MLM29U2X85",
                "RHO26O1T9V",
                "2679MF687A",
                "S033EH8359",
                "8K0I04919X",
                "81G40H8B0T",
                "K72I3DEX9B",
                "568ET80C3D",
                "LRX7AJ16DT",
                "R5L488RY0Q",
                "SK47B8698T",
                "W00LYS4T26",
                "89DS0H96TB",
                "6K2W7T9V6Y",
                "A150AY412V",
                "81AH48963U",
                "H6241UJ22B",
                "3LE3D9D6OY",
                "SOI2LOH54Z"
              ],
              "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": "ZYRTEC",
            "drugstructuredosagenumb": "10",
            "drugstructuredosageunit": "003",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
            "drugdosagetext": "10 MG",
            "drugadministrationroute": "048",
            "openfda": {
              "application_number": [
                "NDA021621"
              ],
              "brand_name": [
                "ZYRTEC"
              ],
              "generic_name": [
                "CETIRIZINE HYDROCHLORIDE"
              ],
              "manufacturer_name": [
                "Kenvue Brands LLC"
              ],
              "product_ndc": [
                "50580-753"
              ],
              "product_type": [
                "HUMAN OTC DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "CETIRIZINE HYDROCHLORIDE"
              ],
              "rxcui": [
                "1014674",
                "1020022"
              ],
              "spl_id": [
                "506ace58-15cc-77b4-e063-6394a90a0813"
              ],
              "spl_set_id": [
                "dc613bd5-70fd-1d9b-e053-2995a90a41cd"
              ],
              "package_ndc": [
                "50580-753-24"
              ],
              "unii": [
                "64O047KTOA"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "PLAVIX",
            "drugseparatedosagenumb": "1",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
            "drugadministrationroute": "048",
            "openfda": {
              "application_number": [
                "NDA020839"
              ],
              "brand_name": [
                "PLAVIX"
              ],
              "generic_name": [
                "CLOPIDOGREL"
              ],
              "manufacturer_name": [
                "Sanofi-Aventis U.S. LLC"
              ],
              "product_ndc": [
                "0024-1171",
                "0024-1332"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "CLOPIDOGREL BISULFATE"
              ],
              "rxcui": [
                "213169",
                "309362",
                "749196",
                "749198"
              ],
              "spl_id": [
                "ed60a9e7-49f4-469c-bb7a-08e1bb6057e2"
              ],
              "spl_set_id": [
                "de8b0b67-eb25-4684-83b5-7ad785314227"
              ],
              "package_ndc": [
                "0024-1171-90",
                "0024-1332-30"
              ],
              "unii": [
                "08I79HTP27"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "ALBUTEROL",
            "drugadministrationroute": "055",
            "openfda": {
              "application_number": [
                "ANDA210948",
                "ANDA219409",
                "ANDA213657",
                "ANDA208804",
                "ANDA207046",
                "ANDA208884"
              ],
              "brand_name": [
                "ALBUTEROL"
              ],
              "generic_name": [
                "ALBUTEROL SULFATE",
                "ALBUTEROL"
              ],
              "manufacturer_name": [
                "Nivagen Pharmaceuticals Inc",
                "Cipla USA Inc.",
                "Aurobindo Pharma Limited",
                "Amneal Pharmaceuticals NY LLC",
                "Rising Pharma Holdings, Inc.",
                "Zydus Pharmaceuticals USA Inc.",
                "Zydus Lifesciences Limited"
              ],
              "product_ndc": [
                "75834-273",
                "75834-274",
                "69097-021",
                "59651-333",
                "59651-334",
                "69238-1344",
                "69238-1345",
                "64980-442",
                "64980-443",
                "70710-1061",
                "70710-1062",
                "70771-1511",
                "70771-1512"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL",
                "RESPIRATORY (INHALATION)"
              ],
              "substance_name": [
                "ALBUTEROL SULFATE"
              ],
              "rxcui": [
                "197316",
                "197318",
                "2123076"
              ],
              "spl_id": [
                "5b89a3bb-e3bb-421d-89f7-f180e01a1b4d",
                "7d4c1e96-c05f-4ffc-80b6-988986a061bc",
                "f89dffb1-5c4b-48aa-90b4-74043fc9b690",
                "efcb5cab-b9c0-4ef9-84fc-5f321c13a0ed",
                "f3d2f709-6e2e-4c25-8069-52661dc76e2d",
                "1d5b3219-efd5-4842-9b6e-2ea1874d0d4d",
                "f4ea29a0-b1df-4ca8-9438-1f0300eb6d9d"
              ],
              "spl_set_id": [
                "b735e92d-eb1a-6fc1-e053-2995a90afce2",
                "fd0389e0-3713-42e0-8ef2-3bb97676fded",
                "ff9b287b-e4a4-4c12-ad2f-6b7d55b20dc6",
                "230d66fc-f62c-42a6-adb3-0a0f879c8ad4",
                "40f3cdbc-c9ee-4a3c-8061-a44b9a1d035c",
                "c3fa0068-fd12-45de-818e-e929fb45ba05",
                "a4709eea-e4a2-46e2-850f-1e6afca01893"
              ],
              "package_ndc": [
                "75834-273-01",
                "75834-274-01",
                "69097-021-60",
                "59651-333-01",
                "59651-333-05",
                "59651-334-01",
                "59651-334-05",
                "69238-1344-1",
                "69238-1344-5",
                "69238-1345-1",
                "69238-1345-5",
                "64980-442-01",
                "64980-442-50",
                "64980-443-01",
                "64980-443-50",
                "70710-1061-1",
                "70710-1062-1",
                "70710-1062-5",
                "70771-1511-1",
                "70771-1512-1",
                "70771-1512-5"
              ],
              "unii": [
                "021SEF3731"
              ]
            }
          }
        ]
      }
    }
  ]
}