SEROQUEL

Orange BookUNIISPLATC N05AH04

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

Identification

ManufacturerH2-Pharma, LLC

CountryUS (United States)

ATC codeN05AH04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6126927160
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (61269-271-60)

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": "61269-271_30d64c02-e070-43b8-9c96-3f7b112c5f7c",
  "productndc": "61269-271",
  "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": "20090201",
  "active_numerator_strength": "150"
}

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