Exforge HCT

{
  "unii": {
    "unii": "864V2Q084H",
    "rxcui": "104416",
    "inchikey": "ZPBWCRDSRKPIDG-UHFFFAOYSA-N",
    "display_name": "AMLODIPINE BESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d0caec89-96ec-411d-a933-63eda74a6da7": {
      "match": "brand_token",
      "title": "EXFORGE (AMLODIPINE BESYLATE AND VALSARTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "36",
      "published_date": "2026-02-18"
    }
  },
  "productid": "0078-0560_e10fea42-c6e7-4584-9a0a-0709c5323cd8",
  "productndc": "0078-0560",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "022314",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;12.5MG;160MG",
        "product_no": "001",
        "approval_date": "Apr 30, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;25MG;160MG",
        "product_no": "002",
        "approval_date": "Apr 30, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;12.5MG;160MG",
        "product_no": "003",
        "approval_date": "Apr 30, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;25MG;160MG",
        "product_no": "004",
        "approval_date": "Apr 30, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;25MG;320MG",
        "product_no": "005",
        "approval_date": "Apr 30, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN",
  "shortage_reason": "Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet",
  "shortage_status": "current",
  "proprietary_name": "Exforge HCT",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "NDA022314",
  "marketing_category": "NDA",
  "nonproprietary_name": "amlodipine valsartan and hydrochlorothiazide",
  "start_marketing_date": "20090404",
  "active_numerator_strength": "5; 25; 160"
}