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United States · US · US:16729-141_40aa4dd3-36ca-1132-e063-6394a90a268d
Clozapine
Orange BookUNIISPLATC N05AH02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAccord Healthcare Inc.
CountryUS (United States)
ATC codeN05AH02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc111672914101100 TABLET in 1 BOTTLE (16729-141-01)
- ndc111672914116500 TABLET in 1 BOTTLE (16729-141-16)
Annotations
UNII (FDA Substance ID)
J60AR2IKIC
CLOZAPINE
RxCUI 2626
Orange Book
A202873
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "J60AR2IKIC",
"rxcui": "2626",
"inchikey": "QZUDBNBUXVUHMW-UHFFFAOYSA-N",
"display_name": "CLOZAPINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"883b5d43-0339-7dc1-f775-93791fb9b978": {
"match": "brand_token",
"title": "CLOZAPINE TABLET [MYLAN PHARMACEUTICALS INC.]",
"spl_version": "35",
"published_date": "2026-05-15"
}
},
"productid": "16729-141_40aa4dd3-36ca-1132-e063-6394a90a268d",
"productndc": "16729-141",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "202873",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Nov 25, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "002",
"approval_date": "Nov 25, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CLOZAPINE",
"proprietary_name": "Clozapine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202873",
"marketing_category": "ANDA",
"nonproprietary_name": "clozapine",
"start_marketing_date": "20170410",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N05AH02.
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