Olanzapine

Orange BookUNIISPLATC N05AH03

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

Identification

ManufacturerAscend Laboratories, LLC

CountryUS (United States)

ATC codeN05AH03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6787717301
100 TABLET in 1 BOTTLE (67877-173-01)
ndc11
6787717310
1000 TABLET in 1 BOTTLE (67877-173-10)
ndc11
6787717330
30 TABLET in 1 BOTTLE (67877-173-30)
ndc11
6787717332
7 TABLET in 1 BOTTLE (67877-173-32)
ndc11
6787717335
10 BLISTER PACK in 1 CARTON (67877-173-35) / 10 TABLET in 1 BLISTER PACK (67877-173-33)
ndc11
6787717385
3 BLISTER PACK in 1 CARTON (67877-173-85) / 10 TABLET in 1 BLISTER PACK (67877-173-33)

Annotations

UNII (FDA Substance ID)

N7U69T4SZR

OLANZAPINE

RxCUI 61381

Orange Book

A202295

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": "67877-173_b4d4d6f0-2b78-4882-add2-7c6218270b7f",
  "productndc": "67877-173",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202295",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Oct 20, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Oct 20, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "003",
        "approval_date": "Oct 20, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Oct 20, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "005",
        "approval_date": "Oct 20, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "006",
        "approval_date": "Oct 20, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OLANZAPINE",
  "proprietary_name": "Olanzapine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202295",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Olanzapine",
  "start_marketing_date": "20120101",
  "active_numerator_strength": "5"
}

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