Quetiapine fumarate

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
7133513621
30 TABLET, FILM COATED in 1 BOTTLE (71335-1362-1)
ndc11
7133513622
100 TABLET, FILM COATED in 1 BOTTLE (71335-1362-2)
ndc11
7133513623
120 TABLET, FILM COATED in 1 BOTTLE (71335-1362-3)
ndc11
7133513624
90 TABLET, FILM COATED in 1 BOTTLE (71335-1362-4)
ndc11
7133513625
60 TABLET, FILM COATED in 1 BOTTLE (71335-1362-5)

Annotations

UNII (FDA Substance ID)

2S3PL1B6UJ

QUETIAPINE FUMARATE

RxCUI 221153

Orange Book

A203359

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": "71335-1362_0a8804e2-28c3-4f92-bf7a-c26c8d00cc71",
  "productndc": "71335-1362",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203359",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "May 17, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "002",
        "approval_date": "May 17, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "003",
        "approval_date": "May 17, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 200MG BASE",
        "product_no": "004",
        "approval_date": "May 17, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 300MG BASE",
        "product_no": "005",
        "approval_date": "May 17, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 400MG BASE",
        "product_no": "006",
        "approval_date": "May 17, 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": "ANDA203359",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Quetiapine fumarate",
  "start_marketing_date": "20160614",
  "active_numerator_strength": "200"
}

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