Diovan HCT

{
  "unii": {
    "unii": "0J48LPH2TH",
    "rxcui": "5487",
    "inchikey": "JZUFKLXOESDKRF-UHFFFAOYSA-N",
    "display_name": "HYDROCHLOROTHIAZIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d76a0419-05ee-437e-884c-65807aea9569": {
      "match": "brand_token",
      "title": "DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "34",
      "published_date": "2026-02-16"
    }
  },
  "productid": "0078-0383_c42c209a-1ad4-43a9-a4f6-33a435fb44e7",
  "productndc": "0078-0383",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020818",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "12.5MG;80MG",
        "product_no": "001",
        "approval_date": "Mar 6, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "12.5MG;160MG",
        "product_no": "002",
        "approval_date": "Mar 6, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG;160MG",
        "product_no": "003",
        "approval_date": "Jan 17, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "12.5MG;320MG",
        "product_no": "004",
        "approval_date": "Apr 28, 2006"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG;320MG",
        "product_no": "005",
        "approval_date": "Apr 28, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCHLOROTHIAZIDE; VALSARTAN",
  "shortage_reason": "Hydrochlorothiazide; Quinapril Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Diovan HCT",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA020818",
  "marketing_category": "NDA",
  "nonproprietary_name": "valsartan and hydrochlorothiazide",
  "start_marketing_date": "19980306",
  "active_numerator_strength": "25; 160"
}