Quetiapine Fumarate

Orange BookUNIISPLATC N05AH04

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

Identification

ManufacturerAlembic Pharmaceuticals Limited

CountryUS (United States)

ATC codeN05AH04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
4670813510
100 TABLET, FILM COATED in 1 CARTON (46708-135-10)
ndc11
4670813530
30 TABLET, FILM COATED in 1 BOTTLE (46708-135-30)
ndc11
4670813531
100 TABLET, FILM COATED in 1 BOTTLE (46708-135-31)
ndc11
4670813591
1000 TABLET, FILM COATED in 1 BOTTLE (46708-135-91)

Annotations

UNII (FDA Substance ID)

2S3PL1B6UJ

QUETIAPINE FUMARATE

RxCUI 221153

Orange Book

A203390

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": "46708-135_1b3c037f-0cff-49a4-9ef2-5e19fdd21bc6",
  "productndc": "46708-135",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203390",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "Oct 28, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 50MG BASE",
        "product_no": "002",
        "approval_date": "Oct 28, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 100MG BASE",
        "product_no": "003",
        "approval_date": "Oct 28, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 200MG BASE",
        "product_no": "004",
        "approval_date": "Oct 28, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 300MG BASE",
        "product_no": "005",
        "approval_date": "Oct 28, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 400MG BASE",
        "product_no": "006",
        "approval_date": "Oct 28, 2014"
      }
    ],
    "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": "ANDA203390",
  "marketing_category": "ANDA",
  "nonproprietary_name": "quetiapine fumarate",
  "start_marketing_date": "20170221",
  "active_numerator_strength": "50"
}

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