ZEGERID

{
  "unii": {
    "unii": "KG60484QX9",
    "rxcui": "7646",
    "inchikey": "SUBDBMMJDZJVOS-UHFFFAOYSA-N",
    "display_name": "OMEPRAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "cd6868b9-5824-442b-8d65-4db29ecb70a4": {
      "match": "brand_token",
      "title": "ZEGERID (OMEPRAZOLE AND SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULE [SANTARUS, INC..]",
      "spl_version": "53",
      "published_date": "2026-04-02"
    }
  },
  "productid": "68012-104_1d076bd0-8cc0-4327-8032-9a307fc89e71",
  "productndc": "68012-104",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "021849",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Feb 27, 2006"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Feb 27, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OMEPRAZOLE; SODIUM BICARBONATE",
  "proprietary_name": "ZEGERID",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA021849",
  "marketing_category": "NDA",
  "nonproprietary_name": "omeprazole and sodium bicarbonate",
  "start_marketing_date": "20060227",
  "active_numerator_strength": "40; 1100"
}