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United States · US · US:67184-0563_69558fe2-90b3-411a-89bb-2405d37d4998
Olanzapine
Orange BookUNIISPLATC N05AH03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerQilu Pharmaceutical Co., Ltd.
CountryUS (United States)
ATC codeN05AH03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 0
No packs registered.
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": "67184-0563_69558fe2-90b3-411a-89bb-2405d37d4998",
"productndc": "67184-0563",
"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": "7.5"
}Related drugs
Other records sharing ATC code N05AH03.
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