🇺🇸
United States · US · US:71335-1849_e44810bf-246c-4043-bd20-28f512e0e347
KETOCONAZOLE
Orange BookUNIISPLATC D01AC08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeD01AC08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 8
- ndc11713351849110 TABLET in 1 BOTTLE (71335-1849-1)
- ndc11713351849230 TABLET in 1 BOTTLE (71335-1849-2)
- ndc11713351849340 TABLET in 1 BOTTLE (71335-1849-3)
- ndc11713351849460 TABLET in 1 BOTTLE (71335-1849-4)
- ndc1171335184958 TABLET in 1 BOTTLE (71335-1849-5)
- ndc1171335184967 TABLET in 1 BOTTLE (71335-1849-6)
- ndc11713351849714 TABLET in 1 BOTTLE (71335-1849-7)
- ndc11713351849890 TABLET in 1 BOTTLE (71335-1849-8)
Annotations
UNII (FDA Substance ID)
R9400W927I
KETOCONAZOLE
RxCUI 6135
Orange Book
A075912
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": "ORAL",
"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": "71335-1849_e44810bf-246c-4043-bd20-28f512e0e347",
"productndc": "71335-1849",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "075912",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "Jan 10, 2002"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "KETOCONAZOLE",
"proprietary_name": "KETOCONAZOLE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075912",
"marketing_category": "ANDA",
"nonproprietary_name": "ketoconazole",
"start_marketing_date": "20200410",
"active_numerator_strength": "200"
}Related drugs
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