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United States · US · US:0527-3163_002da62b-aec3-8e2a-e063-6294a90a5efc
Olanzapine
Orange BookUNIISPLATC N05AH03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLannett Company, Inc.
CountryUS (United States)
ATC codeN05AH03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11052731633230 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0527-3163-32)
Annotations
UNII (FDA Substance ID)
N7U69T4SZR
OLANZAPINE
RxCUI 61381
Orange Book
A208146
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": "0527-3163_002da62b-aec3-8e2a-e063-6294a90a5efc",
"productndc": "0527-3163",
"dosage_form": "TABLET, ORALLY DISINTEGRATING",
"orange_book": {
"appl_no": "208146",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Jul 2, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Jul 2, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "003",
"approval_date": "Jul 2, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "004",
"approval_date": "Jul 2, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OLANZAPINE",
"proprietary_name": "Olanzapine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA208146",
"marketing_category": "ANDA",
"nonproprietary_name": "Olanzapine",
"start_marketing_date": "20230530",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code N05AH03.
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