SEROQUEL

Orange BookUNIISPLATC N05AH04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAstraZeneca Pharmaceuticals LP

CountryUS (United States)

ATC codeN05AH04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0310028360
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0310-0283-60)

Annotations

UNII (FDA Substance ID)

2S3PL1B6UJ

QUETIAPINE FUMARATE

RxCUI 221153

Orange Book

N022047

ABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "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": "0310-0283_8e78eabf-6ff9-409b-ba1b-d9cb8d4f3fe0",
  "productndc": "0310-0283",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "022047",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "May 17, 2007"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 200MG BASE",
        "product_no": "002",
        "approval_date": "May 17, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 300MG BASE",
        "product_no": "003",
        "approval_date": "May 17, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 400MG BASE",
        "product_no": "004",
        "approval_date": "May 17, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "005",
        "approval_date": "Aug 11, 2008"
      }
    ],
    "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": "NDA022047",
  "marketing_category": "NDA",
  "nonproprietary_name": "quetiapine",
  "start_marketing_date": "20070716",
  "active_numerator_strength": "300"
}

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