Quetiapine Fumarate ER

Orange BookUNIISPLATC N05AH04

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

Identification

ManufacturerDirect_Rx

CountryUS (United States)

ATC codeN05AH04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7218964230
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-642-30)

Annotations

UNII (FDA Substance ID)

2S3PL1B6UJ

QUETIAPINE FUMARATE

RxCUI 221153

Orange Book

A204253

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": "72189-642_3fb5c81f-ce60-98bf-e063-6294a90a5711",
  "productndc": "72189-642",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "204253",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "001",
        "approval_date": "Nov 29, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 200MG BASE",
        "product_no": "002",
        "approval_date": "Nov 29, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 300MG BASE",
        "product_no": "003",
        "approval_date": "Nov 29, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 400MG BASE",
        "product_no": "004",
        "approval_date": "Nov 29, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "QUETIAPINE FUMARATE",
  "proprietary_name": "Quetiapine Fumarate ER",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204253",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Quetiapine Fumarate ER",
  "start_marketing_date": "20250926",
  "active_numerator_strength": "400"
}

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