PYLERA

{
  "unii": {
    "unii": "R3O80H60KX",
    "rxcui": "1294617",
    "inchikey": "VBVVJMZCAZRTKA-UHFFFAOYSA-H",
    "display_name": "BISMUTH SUBCITRATE POTASSIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "c50626a2-5969-490b-a88a-a4ee45e79615": {
      "match": "brand_token",
      "title": "PYLERA (BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE) CAPSULE [H2-PHARMA, LLC]",
      "spl_version": "4",
      "published_date": "2026-01-21"
    }
  },
  "productid": "61269-381_b0853a86-d7e4-400b-b21b-5379fbabfe0f",
  "productndc": "61269-381",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "050786",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "140MG;125MG;125MG",
        "product_no": "001",
        "approval_date": "Sep 28, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE",
  "proprietary_name": "PYLERA",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "NDA050786",
  "marketing_category": "NDA",
  "nonproprietary_name": "BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE",
  "start_marketing_date": "20250818",
  "active_numerator_strength": "140; 125; 125"
}