🇺🇸
United States · US · US:60505-3278_997c6776-1ac1-bcb1-022c-2c5b6c277395
Olanzapine
Orange BookUNIISPLATC N05AH03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerApotex Corp.
CountryUS (United States)
ATC codeN05AH03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11605053278010 BLISTER PACK in 1 CARTON (60505-3278-0) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
- ndc11605053278330 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (60505-3278-3)
- ndc1160505327881000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (60505-3278-8)
Annotations
UNII (FDA Substance ID)
N7U69T4SZR
OLANZAPINE
RxCUI 61381
Orange Book
A091265
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": "60505-3278_997c6776-1ac1-bcb1-022c-2c5b6c277395",
"productndc": "60505-3278",
"dosage_form": "TABLET, ORALLY DISINTEGRATING",
"orange_book": {
"appl_no": "091265",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Oct 24, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Oct 24, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "003",
"approval_date": "Oct 24, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "004",
"approval_date": "Oct 24, 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": "ANDA091265",
"marketing_category": "ANDA",
"nonproprietary_name": "Olanzapine",
"start_marketing_date": "20111024",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code N05AH03.
Access this data programmatically
Query Olanzapine and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.