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United States · US · US:0143-9199_0143693c-5d42-4674-9b76-06e8e9e0ed63
Olanzapine
Orange BookUNIISPLATC N05AH03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN05AH03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1101439199011 VIAL in 1 CARTON (0143-9199-01) / 2 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
N7U69T4SZR
OLANZAPINE
RxCUI 61381
Orange Book
A218116
AP
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": "INTRAMUSCULAR",
"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": "0143-9199_0143693c-5d42-4674-9b76-06e8e9e0ed63",
"productndc": "0143-9199",
"dosage_form": "INJECTION, POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "218116",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "10MG/VIAL",
"product_no": "001",
"approval_date": "May 16, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OLANZAPINE",
"proprietary_name": "Olanzapine",
"active_ingred_unit": "mg/2mL",
"application_number": "ANDA218116",
"marketing_category": "ANDA",
"nonproprietary_name": "Olanzapine",
"start_marketing_date": "20250918",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N05AH03.
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