Talicia

{
  "unii": {
    "unii": "804826J2HU",
    "rxcui": "133008",
    "inchikey": "MQXQVCLAUDMCEF-CWLIKTDRSA-N",
    "display_name": "AMOXICILLIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "68c4e9dc-dbcf-4151-b6f7-5e4b9922b76f": {
      "match": "brand_token",
      "title": "TALICIA (OMEPRAZOLE MAGNESIUM, AMOXICILLIN AND RIFABUTIN) CAPSULE, DELAYED RELEASE [REDHILL BIOPHARMA LTD]",
      "spl_version": "10",
      "published_date": "2025-12-25"
    }
  },
  "productid": "57841-1150_0649301c-fc4e-42a4-a62d-9a023a3f9f98",
  "productndc": "57841-1150",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "213004",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "250MG;EQ 10MG BASE;12.5MG",
        "product_no": "001",
        "approval_date": "Nov 1, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN",
  "proprietary_name": "Talicia",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "NDA213004",
  "marketing_category": "NDA",
  "nonproprietary_name": "omeprazole magnesium, amoxicillin and rifabutin",
  "start_marketing_date": "20200309",
  "active_numerator_strength": "250; 10; 12.5"
}