{
  "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": "2026-05-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20230308",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        }
      ],
      "application_number": "ANDA217543",
      "sponsor_name": "MARKSANS PHARMA",
      "openfda": {
        "application_number": [
          "ANDA217543"
        ],
        "brand_name": [
          "ORIGINAL STRENGTH HEARTBURN PREVENTION",
          "FAMOTIDINE 10 MG",
          "FAMOTIDINE 20 MG",
          "MAXIMUM STRENGTH ACID CONTROLLER",
          "MAXIMUM STRENGTH ACID REDUCER"
        ],
        "generic_name": [
          "FAMOTIDINE",
          "FAMOTIDINE 10 MG",
          "FAMOTIDINE 20 MG"
        ],
        "manufacturer_name": [
          "KROGER COMPANY",
          "MARKSANS PHARMA LIMITED",
          "BETTER LIVING BRANDS LLC.",
          "TARGET CORPORATION",
          "TIME CAP LABORATORIES,INC"
        ],
        "product_ndc": [
          "41226-719",
          "25000-086",
          "25000-087",
          "21130-027",
          "11673-697",
          "25000-124",
          "49483-720"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FAMOTIDINE"
        ],
        "rxcui": [
          "199047",
          "310273"
        ],
        "spl_id": [
          "1cb86ee4-41c1-1196-e063-6394a90a9199",
          "c1fe0ae2-1d7b-409d-97cb-9e03eeb7f402",
          "01af6236-f4ba-5999-e063-6394a90a3806",
          "18567eaf-6b97-8c6f-e063-6294a90a986d",
          "1c69fac1-3052-45b1-ab46-a3b523347de1",
          "12f9b308-9375-2df3-e063-6394a90a8d22"
        ],
        "spl_set_id": [
          "ea1c2838-acbd-18e0-e053-2a95a90a3522",
          "58b653eb-6539-4b79-9d22-df6eaf35307f",
          "f2c031b4-de86-3a8e-e053-2a95a90a21e0",
          "07a924f1-14cc-4e7d-e063-6394a90ac7f3",
          "5a66206b-35b1-4d86-8574-a1e45cb0772f",
          "fe25e1e2-7158-6fe0-e053-6394a90a3bb1"
        ],
        "package_ndc": [
          "41226-719-06",
          "41226-719-09",
          "25000-086-36",
          "25000-086-03",
          "25000-086-08",
          "25000-086-07",
          "25000-087-36",
          "25000-087-03",
          "25000-087-08",
          "25000-087-05",
          "25000-087-82",
          "21130-027-05",
          "11673-697-52",
          "11673-697-05",
          "11673-697-01",
          "11673-697-20",
          "25000-124-94",
          "25000-124-84",
          "25000-124-68",
          "49483-720-20",
          "49483-720-01"
        ],
        "nui": [
          "N0000000151",
          "N0000175784"
        ],
        "pharm_class_moa": [
          "Histamine H2 Receptor Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "Histamine-2 Receptor Antagonist [EPC]"
        ],
        "unii": [
          "5QZO15J2Z8"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "FAMOTIDINE",
          "active_ingredients": [
            {
              "name": "FAMOTIDINE",
              "strength": "10MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Over-the-counter"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "FAMOTIDINE",
          "active_ingredients": [
            {
              "name": "FAMOTIDINE",
              "strength": "20MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Over-the-counter"
        }
      ]
    }
  ]
}