Nisoldipine

{
  "unii": {
    "unii": "4I8HAB65SZ",
    "rxcui": "7435",
    "inchikey": "VKQFCGNPDRICFG-UHFFFAOYSA-N",
    "display_name": "NISOLDIPINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb": {
      "match": "brand_token",
      "title": "NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]",
      "spl_version": "21",
      "published_date": "2025-11-17"
    }
  },
  "productid": "66993-473_a999e1d0-199c-4631-8a51-8dc27e05f3ab",
  "productndc": "66993-473",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "020356",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Feb 2, 1995"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Feb 2, 1995"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Feb 2, 1995"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "004",
        "approval_date": "Feb 2, 1995"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "34MG",
        "product_no": "005",
        "approval_date": "Jan 2, 2008"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "006",
        "approval_date": "Jan 2, 2008"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "17MG",
        "product_no": "007",
        "approval_date": "Jan 2, 2008"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "8.5MG",
        "product_no": "008",
        "approval_date": "Jan 2, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NISOLDIPINE",
  "proprietary_name": "Nisoldipine",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020356",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Nisoldipine",
  "start_marketing_date": "20120227",
  "active_numerator_strength": "17"
}