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United States · US · US:0378-3813_435c523e-e4fc-4653-9eb7-ff9c194b42ae
Clozapine
Orange BookUNIISPLATC N05AH02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN05AH02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110378381301100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3813-01)
Annotations
UNII (FDA Substance ID)
J60AR2IKIC
CLOZAPINE
RxCUI 2626
Orange Book
A201824
ABABABAB
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": "0378-3813_435c523e-e4fc-4653-9eb7-ff9c194b42ae",
"productndc": "0378-3813",
"dosage_form": "TABLET, ORALLY DISINTEGRATING",
"orange_book": {
"appl_no": "201824",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "002",
"approval_date": "Sep 15, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "003",
"approval_date": "Sep 15, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "004",
"approval_date": "Aug 7, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "005",
"approval_date": "Aug 7, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CLOZAPINE",
"proprietary_name": "Clozapine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA201824",
"marketing_category": "ANDA",
"nonproprietary_name": "clozapine",
"start_marketing_date": "20151102",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N05AH02.
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