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United States · US · US:55150-308_3f2bc4a3-93fe-42c3-aa91-0d1b337b81a6
OLANZAPINE
Orange BookUNIISPLATC N05AH03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEugia US LLC
CountryUS (United States)
ATC codeN05AH03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1155150308011 VIAL, SINGLE-DOSE in 1 CARTON (55150-308-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
- ndc11551503081010 VIAL, SINGLE-DOSE in 1 CARTON (55150-308-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
N7U69T4SZR
OLANZAPINE
RxCUI 61381
Orange Book
A210968
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": "55150-308_3f2bc4a3-93fe-42c3-aa91-0d1b337b81a6",
"productndc": "55150-308",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "210968",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "10MG/VIAL",
"product_no": "001",
"approval_date": "Oct 22, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OLANZAPINE",
"proprietary_name": "OLANZAPINE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210968",
"marketing_category": "ANDA",
"nonproprietary_name": "OLANZAPINE",
"start_marketing_date": "20201022",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N05AH03.
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