SEROQUEL

{
  "unii": {
    "unii": "2S3PL1B6UJ",
    "rxcui": "221153",
    "inchikey": "ZTHJULTYCAQOIJ-WXXKFALUSA-N",
    "display_name": "QUETIAPINE FUMARATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "8ae62aaf-f8c5-417f-baac-0098369ca322": {
      "match": "brand_token",
      "title": "SEROQUEL (QUETIAPINE) TABLET, FILM COATED [H2-PHARMA, LLC]",
      "spl_version": "53",
      "published_date": "2026-04-13"
    }
  },
  "productid": "0310-0272_aef69992-4a20-4d55-b85c-7c0799619ce6",
  "productndc": "0310-0272",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020639",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "Sep 26, 1997"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "002",
        "approval_date": "Sep 26, 1997"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 200MG BASE",
        "product_no": "003",
        "approval_date": "Sep 26, 1997"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "004",
        "approval_date": "Dec 20, 1998"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 300MG BASE",
        "product_no": "005",
        "approval_date": "Jul 26, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 400MG BASE",
        "product_no": "006",
        "approval_date": "Oct 4, 2005"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "007",
        "approval_date": "Oct 4, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "QUETIAPINE FUMARATE",
  "proprietary_name": "SEROQUEL",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020639",
  "marketing_category": "NDA",
  "nonproprietary_name": "quetiapine",
  "start_marketing_date": "19971001",
  "active_numerator_strength": "200"
}