QUETIAPINE FUMARATE

Orange BookUNIISPLATC N05AH04

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

Identification

ManufacturerAccord Healthcare Inc.

CountryUS (United States)

ATC codeN05AH04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1672909512
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-095-12)

Annotations

UNII (FDA Substance ID)

2S3PL1B6UJ

QUETIAPINE FUMARATE

RxCUI 221153

Orange Book

A090681

ABABABAB

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": {
    "16f48034-b8c9-ab2b-e063-6294a90adf65": {
      "match": "brand_token",
      "title": "QUETIAPINE FUMARATE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]",
      "spl_version": "2",
      "published_date": "2026-06-01"
    }
  },
  "productid": "16729-095_4390e24f-daa6-84a2-e063-6294a90a48ab",
  "productndc": "16729-095",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "090681",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "001",
        "approval_date": "May 9, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 200MG BASE",
        "product_no": "002",
        "approval_date": "May 9, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 300MG BASE",
        "product_no": "003",
        "approval_date": "May 9, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 400MG BASE",
        "product_no": "004",
        "approval_date": "Nov 1, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "QUETIAPINE FUMARATE",
  "proprietary_name": "QUETIAPINE FUMARATE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090681",
  "marketing_category": "ANDA",
  "nonproprietary_name": "QUETIAPINE FUMARATE",
  "start_marketing_date": "20190101",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code N05AH04.

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