🇺🇸
United States · US · US:21922-025_21342f09-ce90-49aa-9660-63e01b602ab7
Ketoconazole
Orange BookUNIISPLATC D01AC08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEncube Ethicals, Inc.
CountryUS (United States)
ATC codeD01AC08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1121922025041 TUBE in 1 CARTON (21922-025-04) / 15 g in 1 TUBE
- ndc1121922025051 TUBE in 1 CARTON (21922-025-05) / 30 g in 1 TUBE
- ndc1121922025071 TUBE in 1 CARTON (21922-025-07) / 60 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
R9400W927I
KETOCONAZOLE
RxCUI 6135
Orange Book
A212443
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": "TOPICAL",
"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": "21922-025_21342f09-ce90-49aa-9660-63e01b602ab7",
"productndc": "21922-025",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "212443",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "2%",
"product_no": "001",
"approval_date": "May 20, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "KETOCONAZOLE",
"proprietary_name": "Ketoconazole",
"active_ingred_unit": "mg/g",
"application_number": "ANDA212443",
"marketing_category": "ANDA",
"nonproprietary_name": "Ketoconazole Cream, 2%",
"start_marketing_date": "20210527",
"active_numerator_strength": "20"
}Related drugs
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