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United States · US · US:71209-075_a7f753c2-1d2b-4b4f-b0e5-250bf951e7c6
Olanzapine
Orange BookUNIISPLATC N05AH03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCadila Pharmaceuticals Limited
CountryUS (United States)
ATC codeN05AH03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11712090750130 TABLET in 1 BOTTLE (71209-075-01)
- ndc117120907505100 TABLET in 1 BOTTLE (71209-075-05)
- ndc117120907510500 TABLET in 1 BOTTLE (71209-075-10)
- ndc1171209075111000 TABLET in 1 BOTTLE (71209-075-11)
Annotations
UNII (FDA Substance ID)
N7U69T4SZR
OLANZAPINE
RxCUI 61381
Orange Book
A210022
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": "71209-075_a7f753c2-1d2b-4b4f-b0e5-250bf951e7c6",
"productndc": "71209-075",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "210022",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2.5MG",
"product_no": "001",
"approval_date": "Feb 24, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "002",
"approval_date": "Feb 24, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "7.5MG",
"product_no": "003",
"approval_date": "Feb 24, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "004",
"approval_date": "Feb 24, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "005",
"approval_date": "Feb 24, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "006",
"approval_date": "Feb 24, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OLANZAPINE",
"proprietary_name": "Olanzapine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210022",
"marketing_category": "ANDA",
"nonproprietary_name": "Olanzapine",
"start_marketing_date": "20190213",
"active_numerator_strength": "7.5"
}Related drugs
Other records sharing ATC code N05AH03.
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