AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE

{
  "unii": {
    "unii": "864V2Q084H",
    "rxcui": "104416",
    "inchikey": "ZPBWCRDSRKPIDG-UHFFFAOYSA-N",
    "display_name": "AMLODIPINE BESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e9ecbadb-c548-6fe5-e053-2a95a90a7577": {
      "match": "brand_token",
      "title": "AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]",
      "spl_version": "3",
      "published_date": "2025-06-12"
    }
  },
  "productid": "64380-200_6c98cab6-e7ba-42ba-adf9-71fa67c0a403",
  "productndc": "64380-200",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "201087",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;12.5MG;160MG",
        "product_no": "001",
        "approval_date": "Jun 1, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;25MG;160MG",
        "product_no": "002",
        "approval_date": "Jun 1, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;12.5MG;160MG",
        "product_no": "003",
        "approval_date": "Jun 1, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;25MG;160MG",
        "product_no": "004",
        "approval_date": "Jun 1, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;25MG;320MG",
        "product_no": "005",
        "approval_date": "Jun 1, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN",
  "shortage_reason": "Amlodipine Besylate; Benazepril Hydrochloride Capsule",
  "shortage_status": "current",
  "proprietary_name": "AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "ANDA201087",
  "marketing_category": "ANDA",
  "nonproprietary_name": "amlodipine besylate valsartan hydrochlorothiazide",
  "start_marketing_date": "20220627",
  "active_numerator_strength": "10; 25; 160"
}