🇺🇸
United States · US · US:0168-0099_6eaf555f-3e9c-4811-ae1f-66afda8b2b11
ketoconazole
Orange BookUNIISPLATC D01AC08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
CountryUS (United States)
ATC codeD01AC08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1101680099151 TUBE in 1 CARTON (0168-0099-15) / 15 g in 1 TUBE
- ndc1101680099301 TUBE in 1 CARTON (0168-0099-30) / 30 g in 1 TUBE
- ndc1101680099601 TUBE in 1 CARTON (0168-0099-60) / 60 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
R9400W927I
KETOCONAZOLE
RxCUI 6135
Orange Book
A076294
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": "0168-0099_6eaf555f-3e9c-4811-ae1f-66afda8b2b11",
"productndc": "0168-0099",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "076294",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2%",
"product_no": "001",
"approval_date": "Apr 28, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "KETOCONAZOLE",
"proprietary_name": "ketoconazole",
"active_ingred_unit": "mg/g",
"application_number": "ANDA076294",
"marketing_category": "ANDA",
"nonproprietary_name": "ketoconazole",
"start_marketing_date": "20040428",
"active_numerator_strength": "20"
}Related drugs
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