Isotretinoin

{
  "unii": {
    "unii": "EH28UP18IF",
    "rxcui": "6064",
    "inchikey": "SHGAZHPCJJPHSC-XFYACQKRSA-N",
    "display_name": "ISOTRETINOIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "08529687-26b2-41e5-b6fb-35b4c0d891fe": {
      "match": "brand_token",
      "title": "ISOTRETINOIN CAPSULE, LIQUID FILLED [UPSHER-SMITH LABORATORIES, LLC]",
      "spl_version": "4",
      "published_date": "2026-02-16"
    }
  },
  "productid": "68308-575_52056651-f1ce-4586-9c28-f919591060a4",
  "productndc": "68308-575",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "213571",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "40MG",
        "product_no": "001",
        "approval_date": "Apr 12, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ISOTRETINOIN",
  "proprietary_name": "Isotretinoin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213571",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Isotretinoin",
  "start_marketing_date": "20210903",
  "active_numerator_strength": "40"
}