🇺🇸
United States · US · US:0093-3219_3027539e-261c-4ac2-a25d-c41fcce3da0f
Ketoconazole
Orange BookUNIISPLATC D01AC08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeD01AC08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1100933219151 TUBE in 1 CARTON (0093-3219-15) / 15 g in 1 TUBE
- ndc1100933219301 TUBE in 1 CARTON (0093-3219-30) / 30 g in 1 TUBE
- ndc1100933219921 TUBE in 1 CARTON (0093-3219-92) / 60 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
R9400W927I
KETOCONAZOLE
RxCUI 6135
Orange Book
A075581
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": "0093-3219_3027539e-261c-4ac2-a25d-c41fcce3da0f",
"productndc": "0093-3219",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "075581",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2%",
"product_no": "001",
"approval_date": "Apr 25, 2000"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "KETOCONAZOLE",
"proprietary_name": "Ketoconazole",
"active_ingred_unit": "mg/g",
"application_number": "ANDA075581",
"marketing_category": "ANDA",
"nonproprietary_name": "Ketoconazole",
"start_marketing_date": "20190208",
"active_numerator_strength": "20"
}Related drugs
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