🇺🇸
United States · US · US:35573-433_748e48d8-09d3-413c-b724-883b6b47f01e
KETOCONAZOLE
Orange BookUNIISPLATC D01AC08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBurel Pharmaceuticals, LLC
CountryUS (United States)
ATC codeD01AC08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc113557343302100 TABLET in 1 BOTTLE (35573-433-02)
- ndc11355734333030 TABLET in 1 BOTTLE (35573-433-30)
Annotations
UNII (FDA Substance ID)
R9400W927I
KETOCONAZOLE
RxCUI 6135
Orange Book
A075912
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "R9400W927I",
"rxcui": "6135",
"inchikey": "XMAYWYJOQHXEEK-ZEQKJWHPSA-N;XMAYWYJOQHXEEK-OZXSUGGESA-N",
"display_name": "KETOCONAZOLE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"abc2446c-cdc2-48fe-80f2-cf0038d2a85e": {
"match": "brand_token",
"title": "KETOCONAZOLE (KETOCONAZOLE CREAM, 2%) CREAM [PREFERRED PHARMACEUTICALS INC.]",
"spl_version": "4",
"published_date": "2026-05-20"
}
},
"productid": "35573-433_748e48d8-09d3-413c-b724-883b6b47f01e",
"productndc": "35573-433",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "075912",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "Jan 10, 2002"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "KETOCONAZOLE",
"proprietary_name": "KETOCONAZOLE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075912",
"marketing_category": "ANDA",
"nonproprietary_name": "ketoconazole",
"start_marketing_date": "20200410",
"active_numerator_strength": "200"
}Related drugs
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