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United States · US · US:61269-650_40d4ed67-c51d-40d0-8a32-ecfdbf069f9a
ZYPREXA
Orange BookUNIISPLATC N05AH03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerH2-Pharma LLC
CountryUS (United States)
ATC codeN05AH03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11612696503530 DOSE PACK in 1 CARTON (61269-650-35) / 1 BLISTER PACK in 1 DOSE PACK (61269-650-01) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
N7U69T4SZR
OLANZAPINE
RxCUI 61381
Orange Book
N021086
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": {
"11544cba-64a9-49cb-8d74-da228053b252": {
"match": "brand_token",
"title": "ZYPREXA RELPREVV (OLANZAPINE PAMOATE) KIT [H2-PHARMA LLC]",
"spl_version": "68",
"published_date": "2026-05-21"
}
},
"productid": "61269-650_40d4ed67-c51d-40d0-8a32-ecfdbf069f9a",
"productndc": "61269-650",
"dosage_form": "TABLET, ORALLY DISINTEGRATING",
"orange_book": {
"appl_no": "021086",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Apr 6, 2000"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Apr 6, 2000"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "15MG",
"product_no": "003",
"approval_date": "Apr 6, 2000"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "20MG",
"product_no": "004",
"approval_date": "Apr 6, 2000"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OLANZAPINE",
"proprietary_name": "ZYPREXA",
"active_ingred_unit": "mg/1",
"application_number": "NDA021086",
"marketing_category": "NDA",
"nonproprietary_name": "Olanzapine",
"start_marketing_date": "20000601",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code N05AH03.
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