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United States · US · US:13668-088_1a64829a-2434-4c8d-8e58-9b28758e4b88

OLANZAPINE

Orange BookUNIISPLATC N05AH03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerTorrent Pharmaceuticals Limited
CountryUS (United States)
ATC codeN05AH03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    1366808805
    500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-088-05)
  • ndc11
    1366808830
    30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-088-30)
  • ndc11
    1366808890
    90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-088-90)

Annotations

UNII (FDA Substance ID)
N7U69T4SZR
OLANZAPINE
RxCUI 61381
Orange Book
A091415
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "N7U69T4SZR",
    "rxcui": "61381",
    "inchikey": "KVWDHTXUZHCGIO-UHFFFAOYSA-N",
    "display_name": "OLANZAPINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "52b99337-afa8-a6f9-e063-6294a90a2038": {
      "match": "brand_token",
      "title": "OLANZAPINE TABLET, FILM COATED [COUPLER LLC]",
      "spl_version": "1",
      "published_date": "2026-05-28"
    }
  },
  "productid": "13668-088_1a64829a-2434-4c8d-8e58-9b28758e4b88",
  "productndc": "13668-088",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "091415",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Oct 25, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Oct 25, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "003",
        "approval_date": "Oct 25, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "004",
        "approval_date": "Oct 25, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OLANZAPINE",
  "proprietary_name": "OLANZAPINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091415",
  "marketing_category": "ANDA",
  "nonproprietary_name": "OLANZAPINE",
  "start_marketing_date": "20111025",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N05AH03.

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