Quetiapine

Orange BookUNIISPLATC N05AH04

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeN05AH04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6362971161
30 TABLET, FILM COATED in 1 BOTTLE (63629-7116-1)
ndc11
6362971162
28 TABLET, FILM COATED in 1 BOTTLE (63629-7116-2)
ndc11
6362971163
60 TABLET, FILM COATED in 1 BOTTLE (63629-7116-3)
ndc11
6362971164
180 TABLET, FILM COATED in 1 BOTTLE (63629-7116-4)
ndc11
6362971165
90 TABLET, FILM COATED in 1 BOTTLE (63629-7116-5)

Annotations

UNII (FDA Substance ID)

2S3PL1B6UJ

QUETIAPINE FUMARATE

RxCUI 221153

Orange Book

A202152

ABABABABABAB

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": "63629-7116_e4115f00-9922-479a-9523-391357dd406d",
  "productndc": "63629-7116",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202152",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "Mar 27, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "002",
        "approval_date": "Mar 27, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "003",
        "approval_date": "Mar 27, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 200MG BASE",
        "product_no": "004",
        "approval_date": "Mar 27, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 300MG BASE",
        "product_no": "005",
        "approval_date": "Mar 27, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 400MG BASE",
        "product_no": "006",
        "approval_date": "Mar 27, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "QUETIAPINE FUMARATE",
  "proprietary_name": "Quetiapine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202152",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Quetiapine",
  "start_marketing_date": "20120328",
  "active_numerator_strength": "400"
}

Related drugs

Other records sharing ATC code N05AH04.

Access this data programmatically

Query Quetiapine and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs