🇺🇸
United States · US · US:72189-422_4d3a9c62-805c-df8c-e063-6294a90aa498
Ketoconazole Cream
Orange BookUNIISPLATC D01AC08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDirect_Rx
CountryUS (United States)
ATC codeD01AC08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11721894223030 g in 1 TUBE (72189-422-30)
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": "72189-422_4d3a9c62-805c-df8c-e063-6294a90aa498",
"productndc": "72189-422",
"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 Cream",
"active_ingred_unit": "mg/g",
"application_number": "ANDA212443",
"marketing_category": "ANDA",
"nonproprietary_name": "Ketoconazole Cream",
"start_marketing_date": "20230207",
"active_numerator_strength": "20"
}Related drugs
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