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United States · US · US:0002-4453_9073f34c-307c-4a3a-8273-580ef5742229

ZYPREXA

Orange BookUNIISPLATC N05AH03

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

Identification

ManufacturerEli Lilly and Company
CountryUS (United States)
ATC codeN05AH03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0002445385
    30 DOSE PACK in 1 CARTON (0002-4453-85) / 1 BLISTER PACK in 1 DOSE PACK (0002-4453-01) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
N7U69T4SZR
OLANZAPINE
RxCUI 61381
Orange Book
N021086
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": {
    "11544cba-64a9-49cb-8d74-da228053b252": {
      "match": "brand_token",
      "title": "ZYPREXA RELPREVV (OLANZAPINE PAMOATE) KIT [H2-PHARMA LLC]",
      "spl_version": "68",
      "published_date": "2026-05-21"
    }
  },
  "productid": "0002-4453_9073f34c-307c-4a3a-8273-580ef5742229",
  "productndc": "0002-4453",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "021086",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Apr 6, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Apr 6, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "003",
        "approval_date": "Apr 6, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "004",
        "approval_date": "Apr 6, 2000"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OLANZAPINE",
  "proprietary_name": "ZYPREXA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021086",
  "marketing_category": "NDA",
  "nonproprietary_name": "Olanzapine",
  "start_marketing_date": "20000601",
  "active_numerator_strength": "5"
}

Related drugs

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