QUETIAPINE

Orange BookUNIISPLATC N05AH04

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

Identification

ManufacturerSolco Healthcare U.S., LLC

CountryUS (United States)

ATC codeN05AH04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4354701906
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-019-06)
ndc11
4354701950
500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-019-50)

Annotations

UNII (FDA Substance ID)

BGL0JSY5SI

QUETIAPINE

RxCUI 51272

Orange Book

A208781

ABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "BGL0JSY5SI",
    "rxcui": "51272",
    "inchikey": "URKOMYMAXPYINW-UHFFFAOYSA-N",
    "display_name": "QUETIAPINE",
    "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": "43547-019_058aac79-3e9f-46b2-a2f8-693ffb211aef",
  "productndc": "43547-019",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "208781",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "Apr 26, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "002",
        "approval_date": "Apr 26, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 200MG BASE",
        "product_no": "003",
        "approval_date": "Apr 26, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 300MG BASE",
        "product_no": "004",
        "approval_date": "Apr 26, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 400MG BASE",
        "product_no": "005",
        "approval_date": "Mar 11, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "QUETIAPINE",
  "proprietary_name": "QUETIAPINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208781",
  "marketing_category": "ANDA",
  "nonproprietary_name": "quetiapine",
  "start_marketing_date": "20220401",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code N05AH04.

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