OLANZAPINE

Orange BookUNIISPLATC N05AH03

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

Identification

ManufacturerTorrent Pharmaceuticals Limited

CountryUS (United States)

ATC codeN05AH03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
1366816901
100 TABLET in 1 BOTTLE (13668-169-01)
ndc11
1366816905
500 TABLET in 1 BOTTLE (13668-169-05)
ndc11
1366816910
1000 TABLET in 1 BOTTLE (13668-169-10)
ndc11
1366816915
1500 TABLET in 1 BOTTLE (13668-169-15)
ndc11
1366816930
30 TABLET in 1 BOTTLE (13668-169-30)
ndc11
1366816960
60 TABLET in 1 BOTTLE (13668-169-60)

Annotations

UNII (FDA Substance ID)

N7U69T4SZR

OLANZAPINE

RxCUI 61381

Orange Book

A091434

ABABABABABAB

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": "13668-169_1a64829a-2434-4c8d-8e58-9b28758e4b88",
  "productndc": "13668-169",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "091434",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Apr 23, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Apr 23, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "003",
        "approval_date": "Apr 23, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Apr 23, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "005",
        "approval_date": "Apr 23, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "006",
        "approval_date": "Apr 23, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OLANZAPINE",
  "proprietary_name": "OLANZAPINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091434",
  "marketing_category": "ANDA",
  "nonproprietary_name": "OLANZAPINE",
  "start_marketing_date": "20260228",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N05AH03.

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