{
  "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": "2026-08-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20200121",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "65832",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/207193Orig1s003s011.pdf",
              "date": "20210106",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20200121",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "65831",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/207193Orig1s003s011.pdf",
              "date": "20210106",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20170818",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN",
          "application_docs": [
            {
              "id": "49508",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207193Orig1s000ltr.pdf",
              "date": "20170822",
              "type": "Letter"
            },
            {
              "id": "49516",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207193Orig1s000lbl.pdf",
              "date": "20170822",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "ANDA207193",
      "sponsor_name": "PERRIGO R AND D",
      "openfda": {
        "application_number": [
          "ANDA207193"
        ],
        "brand_name": [
          "KIRKLAND SIGNATURE ESOMEPRAZOLE MAGNESIUM",
          "ESOMEPRAZOLE MAGNESIUM",
          "ESOMEPRAZOLE MAGNESIUM MINIS",
          "DG HEALTH ESOMEPRAZOLE MAGNESIUM",
          "LEADER ESOMEPRAZOLE MAGNESIUM",
          "GOOD NEIGHBOR PHARMACY ESOMEPRAZOLE MAGNESIUM",
          "EQUATE ESOMEPRAZOLE MAGNESIUM",
          "TOPCARE ESOMEPRAZOLE MAGNESIUM",
          "SIGNATURE CARE ESOMEPRAZOLE MAGNESIUM",
          "BASIC CARE ESOMEPRAZOLE MAGNESIUM",
          "GOOD SENSE ESOMEPRAZOLE MAGNESIUM",
          "MEMBERS MARK ESOMEPRAZOLE MAGNESIUM",
          "EXCHANGE SELECT ESOMEPRAZOLE MAGNESIUM",
          "UP AND UP ESOMEPRAZOLE MAGNESIUM",
          "CAREONE ESOMEPRAZOLE MAGNESIUM",
          "BERKLEY AND JENSEN HEARTBURN TREATMENT",
          "FOSTER AND THRIVE ACID REDUCER"
        ],
        "generic_name": [
          "ESOMEPRAZOLE",
          "ESOMEPRAZOLE MAGNESIUM DIHYDRATE",
          "ESOMEPRAZOLE MAGNESIUM"
        ],
        "manufacturer_name": [
          "Costco Wholesale Company",
          "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED",
          "Dolgencorp, LLC",
          "Cardinal Health 110, LLC. dba Leader",
          "Amerisource Bergen",
          "CVS Pharmacy",
          "Wal-Mart Stores Inc",
          "HyVee Inc",
          "Dolgencorp Inc",
          "Topco Associates LLC",
          "Safeway",
          "H E B",
          "Amazon.com Services LLC",
          "Rite Aid Corporation",
          "L. Perrigo Company",
          "Sam's West Inc",
          "Army & Air Force Exchange Service",
          "Target Corporation",
          "American Sales Company",
          "Walgreen Company",
          "Meijer Distribution Inc",
          "Publix Super Markets Inc",
          "Meijer, Inc.",
          "BJWC",
          "WALMART INC.",
          "Strategic Sourcing Services LLC",
          "Kroger Company"
        ],
        "product_ndc": [
          "63981-898",
          "51316-220",
          "51316-174",
          "55910-250",
          "70000-0727",
          "46122-641",
          "69842-898",
          "49035-921",
          "42507-898",
          "55910-593",
          "36800-627",
          "21130-714",
          "37808-719",
          "21130-088",
          "55910-640",
          "72288-700",
          "11822-0024",
          "72288-898",
          "42507-774",
          "0113-0651",
          "11822-0898",
          "68196-898",
          "55301-898",
          "11673-898",
          "0113-2022",
          "41520-727",
          "11673-753",
          "0363-7223",
          "41250-727",
          "56062-898",
          "0363-1699",
          "72288-669",
          "79481-0411",
          "68391-898",
          "79903-293",
          "72288-560",
          "0113-0898",
          "41250-900",
          "70677-1099",
          "30142-273",
          "69842-703",
          "72288-780",
          "79903-419"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ESOMEPRAZOLE",
          "ESOMEPRAZOLE MAGNESIUM DIHYDRATE"
        ],
        "rxcui": [
          "606726"
        ],
        "spl_id": [
          "7eb4e2fc-b372-464a-b0aa-d63d52c6717e",
          "ff0d65ca-7ca9-4689-b5f9-1065402c91b2",
          "2fe9dc4e-ba53-46be-b3ee-919c9abcf5a2",
          "3924ab5d-59a4-41c0-9ff8-b03ac6dd317a",
          "70bfe4f8-4dba-4b46-abbd-7ff48928c9d5",
          "855c9137-5be7-405e-82af-61c6cd8ed401",
          "49ebfeb6-d3ff-4eca-a18b-6c54d6dae782",
          "d4a545cc-a934-4205-97e0-ceb4550d86d1",
          "320a5a94-ab7d-4d44-9201-b73e7aab50e5",
          "1c810178-5b0b-4390-bf2e-ee36839b2617",
          "61351d9f-87dd-4586-a46a-9ab7fabe41ce",
          "f00018f1-772f-4ac0-a1fe-41c1f59c15f0",
          "e03b4775-6fd8-4d45-83e8-bc405104c539",
          "71c83766-70ff-401d-901a-41f66ed26f55",
          "d5a842f3-d21b-4ddf-87f1-e44daf5cfe05",
          "4df7a0fa-f656-49a8-85fb-2ad2ee20bf28",
          "8fc50397-c8e2-4b2b-9fd6-8ad14f6a3fd6",
          "2eb11ddf-dd57-441d-beb9-23690187f152",
          "bf94aa95-9b11-496b-9f75-1d0c5df15d2e",
          "d4793305-cd87-49cc-b1b1-7c891c986d88",
          "aea67549-d9d2-4431-8973-a5b6a6909a03",
          "566fb836-800f-4bbc-baf0-5ae366d06d55",
          "1ee6f7c0-dff3-4372-a901-c2adef3902b1",
          "77452ea9-bfd7-426f-9a66-1f5f759b4295",
          "674a7792-7ba0-4a78-acd3-0dfcde8128d5",
          "96c2b7f1-ae2c-4b41-b58a-183b654a70ff",
          "b5be3ca8-b19c-4b5f-8018-ed6324482490",
          "1b5303d0-8b4e-4420-b976-03ba683923db",
          "c73a6fc4-f4f9-48c8-96a3-0985b1cd0347",
          "dd61324d-e918-43f2-8c65-ddbdf7102fee",
          "2425f611-2717-4486-aff3-82190c0b0d96",
          "9688d181-7842-4957-b438-4f574d943194",
          "aee69f51-77b9-48c9-8de3-2aa42dc88125",
          "ef5ff944-86d5-487c-86df-e255793a9f52",
          "500ecad2-edb3-4e4b-8bec-e7897a22dd17",
          "0c2ceff8-ed3a-425c-8cd7-22600d26406a",
          "34b0e9f8-27ec-49a8-a373-2a43ce42861d",
          "bda89e2d-5798-402f-9ddb-c8f4d7fc9140",
          "5c410f5e-26ec-470a-93cb-9be23e33e788",
          "a0b2b851-7ffd-4143-a57b-0d4f18902268",
          "7987a91c-0545-4606-a87e-5ece3aff596f",
          "29a98c8a-a012-476b-8971-315f06c12edc",
          "4adcde28-8101-4dc3-88e6-c78ba95fc746"
        ],
        "spl_set_id": [
          "4a87d5d5-c98b-4dc5-81be-50183342b047",
          "19fa87e4-8225-4969-9857-1bf43db4427b",
          "c1435a38-b816-45a1-a0f6-4ad0c5b6da58",
          "8f974698-ce9c-4ffb-b77e-9bad2c2ee2a1",
          "c9472b82-d345-4531-bf07-bd55c94876ab",
          "b596055c-98b2-47b1-b174-ae7ad3ba97ee",
          "6f1d75c1-3c0d-41c2-a625-1ee1bf642c32",
          "aaafc536-f846-4019-a629-b52b3f36e682",
          "b0968243-171e-428a-b692-740e0c05a0fc",
          "2b0e555d-3ed5-4ec4-82a6-855351c503b3",
          "86384845-0bea-490b-b04a-5770ef88b639",
          "972bb479-7146-454d-ace4-f9314f0e584e",
          "0d08dd06-8df6-43ff-9033-8eebd215bec1",
          "238b27e3-6993-4213-b7eb-062309398d1b",
          "d5a842f3-d21b-4ddf-87f1-e44daf5cfe05",
          "0b115351-318c-4bd9-935c-704a09bcdf52",
          "c55a4f7a-3b24-47e5-8ade-3b13df003301",
          "2466913b-7292-4dfd-8ac9-429256faacee",
          "c2308fc8-1549-476d-9769-2991051360ad",
          "e54f2cc9-1d5f-4f0a-8bcf-bd5b917d98ec",
          "6996642f-a63e-4be9-aefd-0634e9914c2b",
          "87913038-4b90-40a0-bce5-2d368bd5758c",
          "5fa9089f-90d1-48b6-bb79-c6171eeeaa03",
          "717e5d5b-4bf7-415e-b259-44056bc96d8b",
          "f13088de-6841-453e-acb0-08bbdf9529d1",
          "3f9a2747-8afd-4898-bbfb-5f379293137e",
          "b3d3ad1d-96f8-4f72-ae66-f14940a62882",
          "d6a55d37-c53b-4451-859b-4dbe1988eb9d",
          "1dd30fec-15f4-44b2-a38f-e59ff4da206d",
          "60554fd6-96d5-4e73-b676-332116caa800",
          "29eb7b87-59a4-4d27-ad53-789da7fec427",
          "4ba317eb-e007-4c97-b382-2b7cac0f6845",
          "8799c88f-dafb-4be6-b279-a54d916162fe",
          "2369c948-d46f-4ace-bc51-47477631bc43",
          "2d40c4bf-5b66-420c-9f17-3f31edc40d1a",
          "42dd2e93-776c-4f49-b590-afc7dab6ef2f",
          "4a89b4b5-5c42-44ee-98a9-e26a237aaef7",
          "126c269b-260d-40f4-879d-169c09251c67",
          "32933772-c0ef-46ad-84e5-d70218bcc866",
          "da02c079-ed18-4896-896d-0489c8f43554",
          "dcaaf24a-0fb9-41b9-881a-00fa60796ca9",
          "8f4e5461-8bbb-4e68-a765-4a52d8f0ba99",
          "ce5f2915-327d-4a91-b7fd-e399664a250f"
        ],
        "package_ndc": [
          "63981-898-01",
          "63981-898-03",
          "51316-220-01",
          "51316-220-03",
          "51316-174-00",
          "51316-174-42",
          "55910-250-01",
          "55910-250-02",
          "55910-250-03",
          "70000-0727-2",
          "70000-0727-1",
          "46122-641-63",
          "46122-641-04",
          "69842-898-01",
          "69842-898-02",
          "69842-898-03",
          "49035-921-01",
          "49035-921-02",
          "49035-921-03",
          "49035-921-14",
          "49035-921-28",
          "49035-921-42",
          "42507-898-00",
          "42507-898-42",
          "55910-593-01",
          "55910-593-02",
          "55910-593-03",
          "36800-627-01",
          "36800-627-03",
          "21130-714-01",
          "21130-714-03",
          "37808-719-01",
          "37808-719-03",
          "21130-088-01",
          "21130-088-02",
          "21130-088-03",
          "55910-640-01",
          "72288-700-01",
          "72288-700-03",
          "11822-0024-5",
          "11822-0024-7",
          "72288-898-01",
          "72288-898-03",
          "42507-774-00",
          "42507-774-42",
          "0113-0651-01",
          "0113-0651-02",
          "0113-0651-03",
          "11822-0898-1",
          "11822-0898-2",
          "11822-0898-3",
          "68196-898-01",
          "68196-898-03",
          "55301-898-01",
          "55301-898-03",
          "11673-898-01",
          "11673-898-03",
          "0113-2022-01",
          "0113-2022-02",
          "41520-727-01",
          "41520-727-03",
          "41520-727-02",
          "11673-753-03",
          "11673-753-01",
          "0363-7223-03",
          "0363-7223-01",
          "41250-727-01",
          "41250-727-03",
          "56062-898-01",
          "56062-898-02",
          "56062-898-03",
          "0363-1699-01",
          "0363-1699-03",
          "72288-669-00",
          "72288-669-01",
          "72288-669-03",
          "79481-0411-1",
          "79481-0411-0",
          "68391-898-00",
          "68391-898-03",
          "79903-293-14",
          "79903-293-42",
          "72288-560-01",
          "72288-560-03",
          "0113-0898-01",
          "0113-0898-02",
          "0113-0898-03",
          "41250-900-01",
          "41250-900-02",
          "41250-900-03",
          "70677-1099-1",
          "70677-1099-2",
          "70677-1099-3",
          "30142-273-01",
          "30142-273-03",
          "69842-703-01",
          "69842-703-03",
          "72288-780-00",
          "72288-780-03",
          "79903-419-14",
          "79903-419-42"
        ],
        "nui": [
          "N0000175525",
          "N0000000147",
          "N0000182140"
        ],
        "pharm_class_epc": [
          "Proton Pump Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Proton Pump Inhibitors [MoA]",
          "Cytochrome P450 2C19 Inhibitors [MoA]"
        ],
        "unii": [
          "N3PA6559FT",
          "36H71644EQ"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "ESOMEPRAZOLE MAGNESIUM",
          "active_ingredients": [
            {
              "name": "ESOMEPRAZOLE MAGNESIUM",
              "strength": "EQ 20MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE, DELAYED RELEASE",
          "route": "ORAL",
          "marketing_status": "Over-the-counter"
        }
      ]
    }
  ]
}