{
 "drug": "Mesalamine Capsule, Extended Release",
 "asOf": "2026-10-09",
 "status": "discontinuing",
 "since": "08/25/2026",
 "dayN": 45,
 "cat": "Gastroenterology",
 "companies": [
  "Takeda Pharmaceuticals USA Inc.",
  "Mylan Pharmaceuticals Inc., a Viatris Company"
 ],
 "reasons": [],
 "records": [
  {
   "discontinued_date": "09/16/2026",
   "update_type": "New",
   "initial_posting_date": "09/16/2026",
   "package_ndc": "54092-191-12",
   "generic_name": "Mesalamine Capsule, Extended Release",
   "contact_info": "877 825 3327",
   "related_info": "Product is anticipated to be available until December 31, 2027",
   "openfda": {
    "application_number": [
     "NDA020049"
    ],
    "brand_name": [
     "PENTASA"
    ],
    "generic_name": [
     "MESALAMINE"
    ],
    "manufacturer_name": [
     "Takeda Pharmaceuticals America, Inc."
    ],
    "product_ndc": [
     "54092-191",
     "54092-189"
    ],
    "product_type": [
     "HUMAN PRESCRIPTION DRUG"
    ],
    "route": [
     "ORAL"
    ],
    "substance_name": [
     "MESALAMINE"
    ],
    "rxcui": [
     "206791",
     "314092",
     "476362",
     "580286"
    ],
    "spl_id": [
     "42661699-8fcc-40da-a05d-91906f9973e8"
    ],
    "spl_set_id": [
     "e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606"
    ],
    "package_ndc": [
     "54092-189-81",
     "54092-191-12"
    ],
    "nui": [
     "N0000175781",
     "M0000971"
    ],
    "pharm_class_epc": [
     "Aminosalicylate [EPC]"
    ],
    "pharm_class_cs": [
     "Aminosalicylic Acids [CS]"
    ],
    "unii": [
     "4Q81I59GXC"
    ]
   },
   "update_date": "09/16/2026",
   "therapeutic_category": [
    "Gastroenterology"
   ],
   "dosage_form": "Capsule, Extended Release",
   "presentation": "Pentasa, Capsule, Extended Release, 500 mg (NDC 54092-191-12)",
   "company_name": "Takeda Pharmaceuticals USA Inc.",
   "status": "To Be Discontinued"
  },
  {
   "discontinued_date": "09/16/2026",
   "update_type": "New",
   "initial_posting_date": "09/16/2026",
   "package_ndc": "54092-189-81",
   "generic_name": "Mesalamine Capsule, Extended Release",
   "contact_info": "877 825 3327",
   "related_info": "Product is anticipated to be available until December 31, 2027",
   "openfda": {
    "application_number": [
     "NDA020049"
    ],
    "brand_name": [
     "PENTASA"
    ],
    "generic_name": [
     "MESALAMINE"
    ],
    "manufacturer_name": [
     "Takeda Pharmaceuticals America, Inc."
    ],
    "product_ndc": [
     "54092-189",
     "54092-191"
    ],
    "product_type": [
     "HUMAN PRESCRIPTION DRUG"
    ],
    "route": [
     "ORAL"
    ],
    "substance_name": [
     "MESALAMINE"
    ],
    "rxcui": [
     "206791",
     "314092",
     "476362",
     "580286"
    ],
    "spl_id": [
     "42661699-8fcc-40da-a05d-91906f9973e8"
    ],
    "spl_set_id": [
     "e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606"
    ],
    "package_ndc": [
     "54092-189-81",
     "54092-191-12"
    ],
    "nui": [
     "N0000175781",
     "M0000971"
    ],
    "pharm_class_epc": [
     "Aminosalicylate [EPC]"
    ],
    "pharm_class_cs": [
     "Aminosalicylic Acids [CS]"
    ],
    "unii": [
     "4Q81I59GXC"
    ]
   },
   "update_date": "09/16/2026",
   "therapeutic_category": [
    "Gastroenterology"
   ],
   "dosage_form": "Capsule, Extended Release",
   "presentation": "Pentasa, Capsule, Extended Release, 250 mg (NDC 54092-189-81)",
   "company_name": "Takeda Pharmaceuticals USA Inc.",
   "status": "To Be Discontinued"
  },
  {
   "discontinued_date": "08/25/2026",
   "update_type": "New",
   "initial_posting_date": "08/25/2026",
   "package_ndc": "0378-1375-78",
   "generic_name": "Mesalamine Capsule, Extended Release",
   "contact_info": "800-796-9526",
   "related_info": "Discontinuation of the manufacture of the drug",
   "openfda": {
    "application_number": [
     "ANDA207271"
    ],
    "brand_name": [
     "MESALAMINE"
    ],
    "generic_name": [
     "MESALAMINE"
    ],
    "manufacturer_name": [
     "Mylan Pharmaceuticals Inc."
    ],
    "product_ndc": [
     "0378-1375"
    ],
    "product_type": [
     "HUMAN PRESCRIPTION DRUG"
    ],
    "route": [
     "ORAL"
    ],
    "substance_name": [
     "MESALAMINE"
    ],
    "rxcui": [
     "825130"
    ],
    "spl_id": [
     "20730160-16c5-4fee-90c9-9c28031ac8f8"
    ],
    "spl_set_id": [
     "c8b93ea3-0367-4605-b87f-06c3812ff3b7"
    ],
    "package_ndc": [
     "0378-1375-78"
    ],
    "nui": [
     "N0000175781",
     "M0000971"
    ],
    "pharm_class_epc": [
     "Aminosalicylate [EPC]"
    ],
    "pharm_class_cs": [
     "Aminosalicylic Acids [CS]"
    ],
    "unii": [
     "4Q81I59GXC"
    ]
   },
   "update_date": "08/25/2026",
   "therapeutic_category": [
    "Gastroenterology"
   ],
   "dosage_form": "Capsule, Extended Release",
   "presentation": "Mesalamine, Capsule, Extended Release, .375 g (NDC 0378-1375-78)",
   "company_name": "Mylan Pharmaceuticals Inc., a Viatris Company",
   "status": "To Be Discontinued"
  }
 ],
 "firstSeen": "2026-08-27",
 "history": [
  {
   "date": "2026-08-27",
   "kind": "new",
   "to": "discontinuing",
   "text": "Mesalamine Capsule, Extended Release appeared on the FDA shortage list (being discontinued)"
  }
 ]
}