Avalide

{
  "unii": {
    "unii": "0J48LPH2TH",
    "rxcui": "5487",
    "inchikey": "JZUFKLXOESDKRF-UHFFFAOYSA-N",
    "display_name": "HYDROCHLOROTHIAZIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "0d91895e-c869-4b33-9b83-d55c1ad6317e": {
      "match": "brand_token",
      "title": "AVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]",
      "spl_version": "24",
      "published_date": "2025-11-17"
    }
  },
  "productid": "0024-5856_5f9089ce-2d9c-4077-8774-acd86b5eff4d",
  "productndc": "0024-5856",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020758",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Sep 30, 1997"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "12.5MG;150MG",
        "product_no": "002",
        "approval_date": "Sep 30, 1997"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "12.5MG;300MG",
        "product_no": "003",
        "approval_date": "Aug 31, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "004",
        "approval_date": "Mar 15, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCHLOROTHIAZIDE; IRBESARTAN",
  "shortage_reason": "Hydrochlorothiazide; Quinapril Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Avalide",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA020758",
  "marketing_category": "NDA",
  "nonproprietary_name": "irbesartan and hydrochlorothiazide",
  "start_marketing_date": "20130101",
  "active_numerator_strength": "12.5; 300"
}