Olanzapine

Orange BookUNIISPLATC N05AH03

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

Identification

ManufacturerUpsher-Smith Laboratories, LLC

CountryUS (United States)

ATC codeN05AH03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0832607903
30 TABLET in 1 BOTTLE (0832-6079-03)
ndc11
0832607950
500 TABLET in 1 BOTTLE (0832-6079-50)

Annotations

UNII (FDA Substance ID)

N7U69T4SZR

OLANZAPINE

RxCUI 61381

Orange Book

A204319

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": "0832-6079_8360dfb0-5f3a-4b86-8b46-fc89c12aad6b",
  "productndc": "0832-6079",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "204319",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Jan 27, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Jan 27, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "003",
        "approval_date": "Jan 27, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Jan 27, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "005",
        "approval_date": "Jan 27, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "006",
        "approval_date": "Jan 27, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OLANZAPINE",
  "proprietary_name": "Olanzapine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204319",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Olanzapine",
  "start_marketing_date": "20160127",
  "active_numerator_strength": "5"
}

Related drugs

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