{
  "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": "2026-08-26",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20150501",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20051104",
          "submission_class_code": "S",
          "submission_class_code_description": "Supplement"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20030204",
          "submission_class_code": "S",
          "submission_class_code_description": "Supplement"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20020815",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "42919",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075010_S003_IBUPROFEN_TABLETS.pdf",
              "date": "20070720",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20001120",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "42917",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/075010_S001_IBUPROFEN TABLETS.pdf",
              "date": "20070720",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19990301",
          "application_docs": [
            {
              "id": "42916",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/075010_ORIGINAL APPROVAL_PACKAGE.pdf",
              "date": "20070720",
              "type": "Review"
            },
            {
              "id": "8488",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75010ltr.pdf",
              "date": "19990301",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20040719",
          "submission_class_code": "S",
          "submission_class_code_description": "Supplement"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20030805",
          "submission_class_code": "S",
          "submission_class_code_description": "Supplement"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20010927",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "42918",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075010_S002_IBUPROFEN_TABLETS.pdf",
              "date": "20070720",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "ANDA075010",
      "sponsor_name": "LNK",
      "openfda": {
        "application_number": [
          "ANDA075010"
        ],
        "brand_name": [
          "IBUPROFEN",
          "MEDIQUE IPRIN",
          "MEDI-FIRST IBUPROFEN",
          "MEDI-FIRST PLUS IBUPROFEN",
          "DOVER ADDAPRIN",
          "GREEN GUARD IBUPRO RELIEF",
          "ULINE IBUPROFEN",
          "HENRY SCHEIN IBUPROFEN",
          "IBUPROFEN 24/7 LIFE BY 7-ELEVEN",
          "IBUPROFEN THOMPSON",
          "PHYSICIANS CARE IBUPROFEN",
          "UNISHIELD IBUPROFEN",
          "CIRCLE K IBUPROFEN",
          "IBUPROFEN, CASEYS 4GOOD",
          "MEDIQUE AT HOME IPRIN",
          "PAIN RELIEF IBUPROFEN",
          "DIRECT SAFETY IBUPROFEN"
        ],
        "generic_name": [
          "IBUPROFEN",
          "IBUPROFEN TABLET, FILM COATED",
          "IBUPROFEN 200MG",
          "IBUPROFEN TABLET, FILM-COATED"
        ],
        "manufacturer_name": [
          "Geritrex LLC",
          "Unifirst First Aid Corporation",
          "Uline",
          "Breeden Brothers, LLC",
          "INGLES MARKETS, INC.",
          "Rite Aid Corporation",
          "Geri-Care Pharmaceutical Corp",
          "Chain Drug Marketing Association, Inc.",
          "H E B",
          "Henry Schein Inc.",
          "Topco Associates, LLC",
          "Meijer Distribution Inc",
          "Chain Drug Consortium",
          "CHAIN DRUG MARKETING ASSOCIATION INC",
          "Wal-Mart Stores Inc",
          "Lil' Drug Store Products, Inc.",
          "Thompson Safety",
          "Lidl US LLC",
          "L.N.K. International, Inc.",
          "Discount Drug Mart",
          "ARMY AND AIR FORCE EXCHANGE SERVICE",
          "Acme United Corporation",
          "Walgreen Company",
          "Wildman Business Group",
          "Unishield",
          "Sam's West Inc",
          "DOLGENCORP, LLC",
          "Lil Drug Store Products, Inc",
          "COSTCO WHOLESALE CORPORATION",
          "Salado Sales, Inc.",
          "CVS Pharmacy",
          "Conney Safety Products, LLC"
        ],
        "product_ndc": [
          "54162-941",
          "47682-600",
          "47682-614",
          "47682-608",
          "47682-609",
          "47682-602",
          "47682-610",
          "69790-609",
          "69790-709",
          "70729-291",
          "62936-0941",
          "11822-0291",
          "57896-941",
          "83324-056",
          "37808-922",
          "0404-0017",
          "36800-292",
          "41250-991",
          "68016-634",
          "63868-773",
          "49035-912",
          "66715-8152",
          "73408-509",
          "73408-809",
          "71141-178",
          "50844-292",
          "50844-257",
          "37808-921",
          "53943-292",
          "55301-291",
          "68016-645",
          "0924-0075",
          "0363-0292",
          "84269-2525",
          "49314-0993",
          "49314-1003",
          "50844-291",
          "68196-291",
          "0363-0291",
          "55910-791",
          "66715-5539",
          "66715-5839",
          "83324-059",
          "66715-6339",
          "29485-9291",
          "63981-291",
          "47682-683",
          "47682-783",
          "63868-979",
          "66715-9819",
          "57243-291",
          "55301-292",
          "59779-291",
          "11822-0292",
          "53943-291",
          "50844-921",
          "61245-085"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "IBUPROFEN"
        ],
        "rxcui": [
          "310965",
          "900434",
          "900438"
        ],
        "spl_id": [
          "f6080edf-c278-4721-8335-4c299adf0c9e",
          "3e5d4984-a2e6-a9fc-e063-6394a90a4396",
          "3e5d431e-d37b-8468-e063-6394a90a0c2a",
          "3e5d77e9-9142-41d7-e063-6294a90a365e",
          "ddc06a6b-1e57-4d1b-83fe-28c4d68c4c8c",
          "efa5fff1-3a7a-202e-e053-2a95a90add3a",
          "755222f1-1733-4c9c-a558-c3ef7f3cb5c1",
          "08f1bde2-f476-2d2f-e063-6294a90a6f93",
          "c10b9cb5-fa7d-4e1b-916c-3449ba8e9ccd",
          "b5c4ef12-5fb1-494c-ac12-c44c08288147",
          "3e4c41a0-acc2-ca87-e063-6294a90a7540",
          "fb3f2380-f159-4522-bf6e-2ed425a63c78",
          "45682185-18cf-431f-b4f1-842f520081b4",
          "4ce3d600-a2ba-4e98-b513-e6e5884ae9a2",
          "c2bb3799-d8e4-4130-973e-9b1b0d7db096",
          "b89a5a36-2c42-4bf5-ad43-39095d834d36",
          "45b3b825-dab8-3328-e063-6294a90a7d2a",
          "3e4f86c4-7e6e-c864-e063-6394a90a59af",
          "d79d3a72-cc60-472a-aef1-28177af06765",
          "310ac7c5-2530-4013-9f56-934a58054bd1",
          "38225d8b-9f4a-4a4b-b4e4-3908bdb7a1a5",
          "6623b567-b36c-42c8-b5a7-e3013c4f4e33",
          "146fac1c-8ce0-40ed-9663-b5748bbace76",
          "a051ad51-edf8-48ab-899c-40bd0b86e071",
          "d2415143-02bb-4721-9d15-68833cbc7efb",
          "42788d11-1807-dfe4-e063-6294a90a477a",
          "07403884-9742-4920-9bae-c32d81417930",
          "9dfd02c5-d499-47e8-8651-f885765a39d1",
          "3e5d6ccc-f765-21b5-e063-6394a90a3400",
          "6de067d7-e53a-48a0-8cf4-bf7d41fa02e0",
          "f8cdb164-4649-4f7b-bbed-31675c05b9f0",
          "fa21aa58-689a-4d59-a48a-445369550ec1",
          "ab690460-e705-4a04-a047-acaf76aa9aca",
          "e9366dd9-28c9-c2c7-e053-2a95a90ad199",
          "0201850e-727c-4fea-9c97-1e06571244f4",
          "0402556a-25f9-7afc-e063-6294a90a77ce",
          "1b4465c6-4eb5-1258-e063-6394a90a6db4",
          "ad3318f9-8f9a-41e6-8ad2-e42a26ce01c8",
          "3e5d5179-6100-176d-e063-6394a90aed0c",
          "17c41cdc-d6d0-40cf-8ac3-ef7ba162b9ba",
          "e5bf5e09-7d43-6314-e053-2a95a90a2325",
          "f86177bc-a5c2-47fe-9ee3-59478a2ec32c",
          "7c77af1f-6777-460c-97d8-12fc49662559",
          "d8135ca1-dfde-4e34-b547-94b7eec64eec",
          "47aebcbb-409b-42ca-87a1-b4b1ecba214a",
          "8f6a852c-e79d-4dad-aa48-af0bab58cd2f",
          "d895e079-d842-4f9f-a97f-c1ac789f83a4",
          "3e5d63ea-c1b9-f7fc-e063-6394a90ae253"
        ],
        "spl_set_id": [
          "ca9498ec-755d-4a09-9504-210dd48d6fed",
          "2910b50b-c8de-382b-e054-00144ff88e88",
          "2923c4a3-f994-67a7-e054-00144ff8d46c",
          "d7342a15-9d49-74ed-e053-2a95a90a22cc",
          "e4314153-479d-4c0f-ba49-4d4efded304b",
          "ef536841-768c-919f-e053-2a95a90af599",
          "d9e698f3-c450-4eaa-9cfd-6f48c2656081",
          "0744c3ca-4224-4f6a-a033-880949b544fd",
          "733d0b21-c177-4c60-9243-2f1e7cb5854a",
          "06173bcd-1e17-4bf8-95e6-d03593585446",
          "267c7c8a-2f3f-1f4d-e054-00144ff8d46c",
          "59a88ca7-eb37-46de-9134-a5a6d330bd49",
          "c0c64ba5-b6b0-4221-9e44-110d92c93782",
          "6c593a9c-680e-4645-8e8f-d8d044c92ca1",
          "bfda6547-19b2-4230-87a1-a68fbec740b4",
          "cb897d65-7e98-4d02-be64-0704416a0f29",
          "45b3b825-dab7-3328-e063-6294a90a7d2a",
          "ccfbc048-f666-3188-e053-2995a90ae08f",
          "b840e98e-be1b-496f-9f0d-3a1a55eb9fe4",
          "d3b8d35a-10b5-a31c-8ced-eeb100c0fd7c",
          "0ef4913b-5dc3-45bc-9cef-58601f8d2a79",
          "4805977f-a30b-4f86-9ef5-e66ad6b8bd53",
          "d0ebf2a7-551b-4acd-be60-2d0b936dd703",
          "718a4b73-5f46-4676-afda-f0b4819f5862",
          "409941dc-9fd3-4475-bc6c-defe3cfbc61a",
          "490c1109-dad7-4135-e054-00144ff8d46c",
          "86818ad6-fd45-4635-9ce8-eac986f008aa",
          "9e71f1c1-5272-4209-8974-6c525b141155",
          "b9e2e2ba-e2ad-eace-e053-2995a90aed35",
          "57b39311-bc20-ace6-75a9-a07a9311b373",
          "6293a134-860d-4d12-9e4b-28490f824108",
          "c118b290-f821-4e73-906e-8a93edaf34e4",
          "37ccb303-c70e-48b3-a8a3-2b0097cf8f88",
          "805d9d80-7de7-49d9-afdb-3a645059fe35",
          "8d518a08-486a-4d11-b042-27fc1e6060c9",
          "0402556a-25f8-7afc-e063-6294a90a77ce",
          "8fc65767-1783-4f7f-8680-9e43ba4d5481",
          "a50abf26-d6e5-10e4-ea90-a40b96a887e5",
          "b5547f33-2a81-867d-e053-2995a90aa2d0",
          "6521bc47-4d9c-4a5b-b109-3841f3be4b6c",
          "e5bf5e09-7d42-6314-e053-2a95a90a2325",
          "06bc4445-5c80-4dd3-b1bb-d9244f45f570",
          "4a0c744f-4ad8-445e-bab1-7ffee35bf861",
          "8d9f11a5-ca98-4280-9c6a-093d32e60ace",
          "c85c3d1f-7639-4cfa-bf3a-424b61757b1a",
          "cffad7af-44f5-4e54-9e46-c3c5d4ca182f",
          "3e6bc53e-9ab1-444c-b555-a85df5d83e68",
          "28d45743-d298-29db-e054-00144ff8d46c"
        ],
        "package_ndc": [
          "54162-941-90",
          "54162-941-00",
          "47682-600-99",
          "47682-600-13",
          "47682-600-47",
          "47682-600-64",
          "47682-600-69",
          "47682-614-99",
          "47682-614-13",
          "47682-608-99",
          "47682-608-30",
          "47682-608-33",
          "47682-608-48",
          "47682-608-13",
          "47682-608-50",
          "47682-609-13",
          "47682-609-33",
          "47682-609-48",
          "47682-602-99",
          "47682-602-13",
          "47682-610-99",
          "47682-610-33",
          "47682-610-48",
          "69790-709-33",
          "69790-609-33",
          "70729-291-12",
          "62936-0941-1",
          "62936-0941-5",
          "11822-0291-2",
          "11822-0291-8",
          "11822-0291-5",
          "11822-0291-1",
          "11822-0291-0",
          "11822-0291-6",
          "11822-0291-9",
          "11822-0291-3",
          "11822-0291-7",
          "11822-0291-4",
          "57896-941-01",
          "57896-941-10",
          "57896-941-05",
          "57896-941-25",
          "57896-941-50",
          "57896-941-20",
          "83324-056-24",
          "83324-056-01",
          "83324-056-50",
          "37808-922-13",
          "0404-0017-99",
          "0404-0017-13",
          "36800-292-06",
          "41250-991-03",
          "68016-634-24",
          "68016-634-50",
          "68016-634-10",
          "68016-634-25",
          "68016-634-05",
          "68016-634-00",
          "63868-773-10",
          "63868-773-05",
          "63868-773-24",
          "63868-773-50",
          "49035-912-15",
          "49035-912-12",
          "49035-912-08",
          "66715-8152-6",
          "73408-809-33",
          "73408-509-33",
          "71141-178-22",
          "71141-178-32",
          "50844-292-02",
          "50844-292-08",
          "50844-292-01",
          "50844-292-15",
          "50844-292-11",
          "50844-292-12",
          "50844-292-00",
          "50844-292-13",
          "50844-292-14",
          "50844-292-16",
          "50844-257-15",
          "37808-921-08",
          "37808-921-14",
          "53943-292-15",
          "53943-292-12",
          "53943-292-14",
          "55301-291-03",
          "55301-291-06",
          "55301-291-12",
          "55301-291-14",
          "68016-645-08",
          "68016-645-15",
          "68016-645-12",
          "0924-0075-00",
          "0924-0075-01",
          "0924-0075-03",
          "0924-0075-02",
          "0924-0075-04",
          "0924-0075-05",
          "0363-0292-08",
          "0363-0292-15",
          "0363-0292-37",
          "0363-0292-12",
          "0363-0292-17",
          "0363-0292-14",
          "84269-2525-2",
          "84269-2525-1",
          "49314-1003-3",
          "49314-0993-3",
          "50844-291-24",
          "50844-291-50",
          "50844-291-03",
          "50844-291-02",
          "50844-291-08",
          "50844-291-01",
          "50844-291-10",
          "50844-291-15",
          "50844-291-11",
          "50844-291-12",
          "50844-291-29",
          "50844-291-99",
          "50844-291-13",
          "50844-291-17",
          "50844-291-14",
          "50844-291-16",
          "68196-291-78",
          "68196-291-14",
          "0363-0291-03",
          "0363-0291-29",
          "0363-0291-14",
          "0363-0291-16",
          "0363-0291-08",
          "0363-0291-37",
          "0363-0291-15",
          "0363-0291-12",
          "0363-0291-57",
          "0363-0291-99",
          "55910-791-96",
          "55910-791-08",
          "66715-5839-2",
          "66715-5839-3",
          "66715-5539-3",
          "83324-059-24",
          "83324-059-50",
          "83324-059-01",
          "66715-6339-3",
          "29485-9291-3",
          "29485-9291-5",
          "29485-9291-2",
          "63981-291-14",
          "63981-291-03",
          "47682-683-99",
          "47682-683-33",
          "47682-783-99",
          "47682-783-33",
          "63868-979-24",
          "63868-979-50",
          "63868-979-10",
          "66715-9819-7",
          "57243-291-15",
          "55301-292-15",
          "55301-292-12",
          "59779-291-10",
          "59779-291-98",
          "59779-291-15",
          "59779-291-12",
          "59779-291-90",
          "59779-291-96",
          "59779-291-05",
          "59779-291-03",
          "59779-291-29",
          "11822-0292-5",
          "11822-0292-2",
          "11822-0292-4",
          "11822-0292-8",
          "11822-0292-6",
          "11822-0292-7",
          "53943-291-15",
          "53943-291-12",
          "53943-291-14",
          "50844-921-12",
          "50844-921-14",
          "50844-921-06",
          "61245-085-13"
        ],
        "nui": [
          "N0000000160",
          "M0001335",
          "N0000175722"
        ],
        "pharm_class_moa": [
          "Cyclooxygenase Inhibitors [MoA]"
        ],
        "pharm_class_cs": [
          "Anti-Inflammatory Agents, Non-Steroidal [CS]"
        ],
        "pharm_class_epc": [
          "Nonsteroidal Anti-inflammatory Drug [EPC]"
        ],
        "unii": [
          "WK2XYI10QM"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "IBUPROFEN",
          "active_ingredients": [
            {
              "name": "IBUPROFEN",
              "strength": "200MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Over-the-counter"
        }
      ]
    }
  ]
}