BiDil

{
  "unii": {
    "unii": "FD171B778Y",
    "rxcui": "82027",
    "inchikey": "ZUXNZUWOTSUBMN-UHFFFAOYSA-N",
    "display_name": "HYDRALAZINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e1e63cd5-d1e4-4af5-bad5-1ad41ea46b00": {
      "match": "brand_token",
      "title": "BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [AZURITY PHARMACEUTICALS, INC.]",
      "spl_version": "13",
      "published_date": "2026-01-22"
    }
  },
  "productid": "24338-010_79524516-67d7-45ef-bf97-878c6dc8d6ef",
  "productndc": "24338-010",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020727",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "37.5MG;20MG",
        "product_no": "001",
        "approval_date": "Jun 23, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE",
  "proprietary_name": "BiDil",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA020727",
  "marketing_category": "NDA",
  "nonproprietary_name": "Hydralazine hydrochloride and Isosorbide dinitrate",
  "start_marketing_date": "20121205",
  "active_numerator_strength": "37.5; 20"
}