REMERON

{
  "unii": {
    "unii": "A051Q2099Q",
    "rxcui": "15996",
    "inchikey": "RONZAEMNMFQXRA-UHFFFAOYSA-N",
    "display_name": "MIRTAZAPINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "98ad1917-a094-44f5-a28f-a64a8cfcd887": {
      "match": "brand_token",
      "title": "REMERON (MIRTAZAPINE) TABLET, FILM COATED REMERONSOLTAB (MIRTAZAPINE) TABLET, ORALLY DISINTEGRATING [ORGANON LLC]",
      "spl_version": "8",
      "published_date": "2025-08-08"
    }
  },
  "productid": "78206-160_8b121c7c-9bcd-4504-b789-3f551a0fe514",
  "productndc": "78206-160",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020415",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "Jun 14, 1996"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Jun 14, 1996"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Mar 17, 1997"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MIRTAZAPINE",
  "proprietary_name": "REMERON",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020415",
  "marketing_category": "NDA",
  "nonproprietary_name": "MIRTAZAPINE",
  "start_marketing_date": "20210601",
  "active_numerator_strength": "15"
}