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": "75987-145_374233b1-345c-4d9e-9bc0-e5aa2f9d8e1f",
  "productndc": "75987-145",
  "dosage_form": "GRANULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "213491",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 75MG BASE/PACKET",
        "product_no": "001",
        "approval_date": "Feb 14, 2020"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 300MG BASE/PACKET",
        "product_no": "002",
        "approval_date": "Feb 14, 2020"
      }
    ],
    "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": "NDA213491",
  "marketing_category": "NDA",
  "nonproprietary_name": "Cysteamine bitartrate",
  "start_marketing_date": "20200214",
  "active_numerator_strength": "300"
}