PROCYSBI

{
  "unii": {
    "unii": "QO84GZ3TST",
    "rxcui": "81990",
    "inchikey": "NSKJTUFFDRENDM-ZVGUSBNCSA-N",
    "display_name": "CYSTEAMINE BITARTRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d3a3ec28-f746-463a-bb92-3bc8826db09e": {
      "match": "brand_token",
      "title": "PROCYSBI (CYSTEAMINE BITARTRATE) CAPSULE, DELAYED RELEASE PELLETS PROCYSBI (CYSTEAMINE BITARTRATE) GRANULE, DELAYED RELEASE [HORIZON THERAPEUTICS USA, INC.]",
      "spl_version": "12",
      "published_date": "2025-04-23"
    }
  },
  "productid": "75987-101_374233b1-345c-4d9e-9bc0-e5aa2f9d8e1f",
  "productndc": "75987-101",
  "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS",
  "orange_book": {
    "appl_no": "203389",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "Apr 30, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 75MG BASE",
        "product_no": "002",
        "approval_date": "Apr 30, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYSTEAMINE BITARTRATE",
  "proprietary_name": "PROCYSBI",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA203389",
  "marketing_category": "NDA",
  "nonproprietary_name": "Cysteamine bitartrate",
  "start_marketing_date": "20130430",
  "active_numerator_strength": "75"
}