PREXXARTAN

{
  "unii": {
    "unii": "80M03YXJ7I",
    "rxcui": "69749",
    "inchikey": "ACWBQPMHZXGDFX-QFIPXVFZSA-N",
    "display_name": "VALSARTAN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "508c5de8-9c70-57f5-e063-6394a90af295": {
      "match": "brand_token",
      "title": "PREXXARTAN SOLUTION [APTAPHARMA INC.]",
      "spl_version": "1",
      "published_date": "2026-05-13"
    }
  },
  "productid": "76281-155_508c61d6-dbb1-5d06-e063-6394a90aa5ec",
  "productndc": "76281-155",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "209139",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Dec 19, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VALSARTAN",
  "shortage_reason": "Valsartan Tablet",
  "shortage_status": "current",
  "proprietary_name": "PREXXARTAN",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA209139",
  "marketing_category": "NDA",
  "nonproprietary_name": "PREXXARTAN",
  "start_marketing_date": "20260505",
  "active_numerator_strength": "4"
}