🇺🇸
United States · US · US:87063-066_491acb10-adec-3d11-e063-6294a90a8e32
Ketoconazole
Orange BookUNIISPLATC D01AC08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerASCLEMED USA INC.
CountryUS (United States)
ATC codeD01AC08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1187063066151 TUBE in 1 CARTON (87063-066-15) / 15 g in 1 TUBE
- ndc1187063066301 TUBE in 1 CARTON (87063-066-30) / 30 g in 1 TUBE
- ndc1187063066601 TUBE in 1 CARTON (87063-066-60) / 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": "87063-066_491acb10-adec-3d11-e063-6294a90a8e32",
"productndc": "87063-066",
"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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