ZOCOR

{
  "unii": {
    "unii": "AGG2FN16EV",
    "rxcui": "36567",
    "inchikey": "RYMZZMVNJRMUDD-HGQWONQESA-N",
    "display_name": "SIMVASTATIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "8f55d5de-5a4f-4a39-8c84-c53976dd6af9": {
      "match": "brand_token",
      "title": "ZOCOR (SIMVASTATIN) TABLET, FILM COATED [ORGANON LLC]",
      "spl_version": "11",
      "published_date": "2025-04-03"
    }
  },
  "productid": "78206-180_11256523-425c-48e8-afe1-e3a4e28c892e",
  "productndc": "78206-180",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "019766",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Dec 23, 1991"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Dec 23, 1991"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "Dec 23, 1991"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "004",
        "approval_date": "Dec 23, 1991"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "005",
        "approval_date": "Jul 10, 1998"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SIMVASTATIN",
  "proprietary_name": "ZOCOR",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA019766",
  "marketing_category": "NDA",
  "nonproprietary_name": "SIMVASTATIN",
  "start_marketing_date": "20210601",
  "active_numerator_strength": "10"
}