Quetiapine Fumarate

Orange BookUNIISPLATC N05AH04

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

Identification

ManufacturerIngenus Pharmaceuticals, LLC

CountryUS (United States)

ATC codeN05AH04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
5074263710
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-637-10)
ndc11
5074263730
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-637-30)
ndc11
5074263760
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-637-60)
ndc11
5074263790
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-637-90)

Annotations

UNII (FDA Substance ID)

2S3PL1B6UJ

QUETIAPINE FUMARATE

RxCUI 221153

Orange Book

A208947

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": {
    "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": "50742-637_57efb2c4-97c7-4f4b-8e1f-e73ec6d6c176",
  "productndc": "50742-637",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "208947",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "Nov 29, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "002",
        "approval_date": "Nov 29, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 200MG BASE",
        "product_no": "003",
        "approval_date": "Nov 29, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 300MG BASE",
        "product_no": "004",
        "approval_date": "Nov 29, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 400MG BASE",
        "product_no": "005",
        "approval_date": "Nov 29, 2017"
      }
    ],
    "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": "ANDA208947",
  "marketing_category": "ANDA",
  "nonproprietary_name": "quetiapine fumarate",
  "start_marketing_date": "20170831",
  "active_numerator_strength": "200"
}

Related drugs

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