{
  "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": "2026-06-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 52
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20240205",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20240205",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20240205",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20240205",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20160715",
          "submission_class_code": "N/A",
          "submission_class_code_description": "Not Applicable",
          "application_docs": [
            {
              "id": "9887",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201361Orig1s000ltr.pdf",
              "date": "20160720",
              "type": "Letter"
            },
            {
              "id": "19014",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201361Orig1s000lbl.pdf",
              "date": "20160721",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "ANDA201361",
      "sponsor_name": "PERRIGO R AND D",
      "openfda": {
        "application_number": [
          "ANDA201361"
        ],
        "brand_name": [
          "EQUATE OMEPRAZOLE AND SODIUM BICARBONATE",
          "OMEPRAZOLE AND SODIUM BICARBONATE",
          "GOOD SENSE OMEPRAZOLE AND SODIUM BICARBONATE",
          "ZEGERID OTC",
          "BASIC CARE OMEPRAZOLE AND SODIUM BICARBONATE"
        ],
        "generic_name": [
          "OMEPRAZOLE, SODIUM BICARBONATE",
          "OMEPRAOLE, SODIUM BICARBONATE"
        ],
        "manufacturer_name": [
          "WALMART INC.",
          "CVS Pharmacy",
          "Meijer Distribution Inc",
          "H E B",
          "Walgreen Company",
          "L. Perrigo Company",
          "Riley Consumer Care LLC",
          "Amazon.com Services LLC"
        ],
        "product_ndc": [
          "79903-013",
          "59779-732",
          "41250-938",
          "37808-732",
          "0363-0732",
          "0113-0058",
          "82632-699",
          "72288-732"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "OMEPRAZOLE",
          "SODIUM BICARBONATE"
        ],
        "rxcui": [
          "616539",
          "646344"
        ],
        "spl_id": [
          "73c4e834-2046-4ead-9783-3098456744b1",
          "a6fecbac-6464-4363-98b8-700b37d8647f",
          "38a77306-7ef0-4938-9486-d327e25a0462",
          "99b31e8b-1cf3-47a5-b0f7-31e0530691ed",
          "418a1ab3-af9c-459d-b8b3-471788d50d8d",
          "6916a481-6168-4c6f-8889-d8a207ce9d97",
          "a67c46ad-327c-4561-92ce-27f6ce3e76c6",
          "d0951437-6ee9-41b2-88b8-1d209dc57ca9"
        ],
        "spl_set_id": [
          "c24c3326-99da-4c7d-aecc-7b4a8ac3f04e",
          "186732a3-13b9-4ea2-ba54-424f63298a2e",
          "bb7c1c5d-b915-42f5-a5a2-5f61b088028d",
          "ddc8d73f-f4a1-42a7-89ee-420346820f61",
          "8753a131-f8b1-48e1-993b-73c1ee635fef",
          "bcf32242-de17-4da1-b707-4ce26262eb78",
          "8d00c19a-d86b-4a2f-8791-b320ad3ca781",
          "4587f491-04ef-4c31-b7b6-bfafd31776fb"
        ],
        "package_ndc": [
          "79903-013-01",
          "79903-013-03",
          "59779-732-01",
          "59779-732-03",
          "41250-938-01",
          "41250-938-03",
          "37808-732-01",
          "37808-732-03",
          "0363-0732-01",
          "0363-0732-03",
          "0113-0058-03",
          "82632-699-01",
          "82632-699-03",
          "72288-732-01",
          "72288-732-03"
        ],
        "nui": [
          "N0000175525",
          "N0000000147",
          "N0000182140"
        ],
        "pharm_class_epc": [
          "Proton Pump Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Proton Pump Inhibitors [MoA]",
          "Cytochrome P450 2C19 Inhibitors [MoA]"
        ],
        "unii": [
          "KG60484QX9",
          "8MDF5V39QO"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "OMEPRAZOLE AND SODIUM BICARBONATE",
          "active_ingredients": [
            {
              "name": "OMEPRAZOLE",
              "strength": "20MG"
            },
            {
              "name": "SODIUM BICARBONATE",
              "strength": "1.1GM"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Over-the-counter"
        }
      ]
    }
  ]
}