Quetiapine

Orange BookUNIISPLATC N05AH04

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

Identification

ManufacturerASCLEMED USA INC.

CountryUS (United States)

ATC codeN05AH04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
7642051301
100 TABLET, FILM COATED in 1 BOTTLE (76420-513-01)
ndc11
7642051310
10 TABLET, FILM COATED in 1 BOTTLE (76420-513-10)
ndc11
7642051320
20 TABLET, FILM COATED in 1 BOTTLE (76420-513-20)
ndc11
7642051330
30 TABLET, FILM COATED in 1 BOTTLE (76420-513-30)
ndc11
7642051360
60 TABLET, FILM COATED in 1 BOTTLE (76420-513-60)
ndc11
7642051390
90 TABLET, FILM COATED in 1 BOTTLE (76420-513-90)

Annotations

UNII (FDA Substance ID)

2S3PL1B6UJ

QUETIAPINE FUMARATE

RxCUI 221153

Orange Book

A201504

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": "76420-513_41a41d6e-d9e9-4f2d-e063-6394a90aa6f5",
  "productndc": "76420-513",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "201504",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "Feb 12, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "002",
        "approval_date": "Feb 12, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "003",
        "approval_date": "Feb 12, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "004",
        "approval_date": "Feb 12, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 200MG BASE",
        "product_no": "005",
        "approval_date": "Feb 12, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 300MG BASE",
        "product_no": "006",
        "approval_date": "Feb 12, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 400MG BASE",
        "product_no": "007",
        "approval_date": "Feb 12, 2013"
      }
    ],
    "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": "ANDA201504",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Quetiapine",
  "start_marketing_date": "20130301",
  "active_numerator_strength": "50"
}

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