Actonel

{
  "unii": {
    "unii": "HU2YAQ274O",
    "rxcui": "1356127",
    "inchikey": "HYFDYHPNTXOPPO-UHFFFAOYSA-L",
    "display_name": "RISEDRONATE SODIUM HEMIPENTAHYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "24ed00e0-25e2-49a8-97fc-66c1b417dc0b": {
      "match": "brand_token",
      "title": "ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [ALLERGAN, INC.]",
      "spl_version": "31",
      "published_date": "2026-05-11"
    }
  },
  "productid": "0430-0478_a874a4b5-3deb-40b1-9cb8-d80c3fca4401",
  "productndc": "0430-0478",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020835",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "30MG",
        "product_no": "001",
        "approval_date": "Mar 27, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Apr 14, 2000"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "35MG",
        "product_no": "003",
        "approval_date": "May 25, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "004",
        "approval_date": "Apr 16, 2007"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "005",
        "approval_date": "Apr 22, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RISEDRONATE SODIUM HEMIPENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE",
  "proprietary_name": "Actonel",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA020835",
  "marketing_category": "NDA",
  "nonproprietary_name": "Risedronate Sodium",
  "start_marketing_date": "20080422",
  "active_numerator_strength": "129; 21"
}