Quetiapine Fumarate

Orange BookUNIISPLATC N05AH04

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeN05AH04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6586249401
100 TABLET, FILM COATED in 1 BOTTLE (65862-494-01)
ndc11
6586249410
10 BLISTER PACK in 1 CARTON (65862-494-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
6586249460
60 TABLET, FILM COATED in 1 BOTTLE (65862-494-60)
ndc11
6586249499
1000 TABLET, FILM COATED in 1 BOTTLE (65862-494-99)

Annotations

UNII (FDA Substance ID)

2S3PL1B6UJ

QUETIAPINE FUMARATE

RxCUI 221153

Orange Book

A091388

ABABABABABABAB

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": "65862-494_f759dcc0-2e6c-4743-8772-3f05602db2a3",
  "productndc": "65862-494",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "091388",
    "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 150MG BASE",
        "product_no": "004",
        "approval_date": "Mar 27, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 200MG BASE",
        "product_no": "005",
        "approval_date": "Mar 27, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 300MG BASE",
        "product_no": "006",
        "approval_date": "Mar 27, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 400MG BASE",
        "product_no": "007",
        "approval_date": "Mar 27, 2012"
      }
    ],
    "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": "ANDA091388",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Quetiapine Fumarate",
  "start_marketing_date": "20120327",
  "active_numerator_strength": "300"
}

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