BREZTRI

{
  "unii": {
    "unii": "Q3OKS62Q6X",
    "rxcui": "19831",
    "inchikey": "VOVIALXJUBGFJZ-KWVAZRHASA-N",
    "display_name": "BUDESONIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RESPIRATORY (INHALATION)",
  "spl_meta": {
    "715433dc-cb2b-43ea-b6df-c5b4177adc6c": {
      "match": "brand_token",
      "title": "BREZTRI (BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE) AEROSOL, METERED [ASTRAZENECA PHARMACEUTICALS LP]",
      "spl_version": "7",
      "published_date": "2026-05-04"
    }
  },
  "productid": "0310-6616_2d00a029-b36a-4a4f-8583-1af78a184682",
  "productndc": "0310-6616",
  "dosage_form": "AEROSOL, METERED",
  "orange_book": {
    "appl_no": "212122",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.16MG/INH;0.0048MG/INH;0.009MG/INH",
        "product_no": "001",
        "approval_date": "Jul 23, 2020"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.16MG/INH;0.0048MG/INH;0.018MG/INH",
        "product_no": "002",
        "approval_date": "Apr 27, 2026"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUDESONIDE; FORMOTEROL; GLYCOPYRROLATE",
  "proprietary_name": "BREZTRI",
  "active_ingred_unit": "ug/1; ug/1; ug/1",
  "application_number": "NDA212122",
  "marketing_category": "NDA",
  "nonproprietary_name": "budesonide, glycopyrrolate, and formoterol fumarate",
  "start_marketing_date": "20260427",
  "active_numerator_strength": "160; 4.8; 7.2"
}