isosorbide dinitrate and hydralazine hydrochloride

{
  "unii": {
    "unii": "FD171B778Y",
    "rxcui": "82027",
    "inchikey": "ZUXNZUWOTSUBMN-UHFFFAOYSA-N",
    "display_name": "HYDRALAZINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c": {
      "match": "brand_token",
      "title": "ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]",
      "spl_version": "13",
      "published_date": "2026-05-13"
    }
  },
  "productid": "73141-012_339fc165-a47c-e0e1-e063-6394a90a4622",
  "productndc": "73141-012",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "215988",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "37.5MG;20MG",
        "product_no": "001",
        "approval_date": "Jan 17, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE",
  "proprietary_name": "isosorbide dinitrate and hydralazine hydrochloride",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA215988",
  "marketing_category": "ANDA",
  "nonproprietary_name": "isosorbide dinitrate and hydralazine hydrochloride",
  "start_marketing_date": "20240422",
  "active_numerator_strength": "37.5; 20"
}