AMLODIPINE AND VALSARTAN

{
  "unii": {
    "unii": "864V2Q084H",
    "rxcui": "104416",
    "inchikey": "ZPBWCRDSRKPIDG-UHFFFAOYSA-N",
    "display_name": "AMLODIPINE BESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "6efc0ef6-0424-44fc-a9ea-eb30c3b83239": {
      "match": "brand_token",
      "title": "AMLODIPINE BESYLATE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "43386-081_8d66a9ba-050e-4993-939b-f2c858760a0c",
  "productndc": "43386-081",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202829",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;160MG",
        "product_no": "001",
        "approval_date": "Mar 30, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;160MG",
        "product_no": "002",
        "approval_date": "Mar 30, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;320MG",
        "product_no": "003",
        "approval_date": "Mar 30, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;320MG",
        "product_no": "004",
        "approval_date": "Mar 30, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMLODIPINE BESYLATE; VALSARTAN",
  "shortage_reason": "Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet",
  "shortage_status": "current",
  "proprietary_name": "AMLODIPINE AND VALSARTAN",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA202829",
  "marketing_category": "ANDA",
  "nonproprietary_name": "amlodipine and valsartan",
  "start_marketing_date": "20150330",
  "active_numerator_strength": "5; 320"
}