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United States · US · US:71335-0439_ae8e3f89-1b77-4934-9252-64d9888d13fd
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
- ndc11713350439110 TABLET in 1 BOTTLE (71335-0439-1)
- ndc11713350439230 TABLET in 1 BOTTLE (71335-0439-2)
- ndc11713350439340 TABLET in 1 BOTTLE (71335-0439-3)
- ndc11713350439460 TABLET in 1 BOTTLE (71335-0439-4)
- ndc1171335043958 TABLET in 1 BOTTLE (71335-0439-5)
- ndc1171335043967 TABLET in 1 BOTTLE (71335-0439-6)
- ndc11713350439714 TABLET in 1 BOTTLE (71335-0439-7)
- ndc11713350439890 TABLET in 1 BOTTLE (71335-0439-8)
Annotations
UNII (FDA Substance ID)
R9400W927I
KETOCONAZOLE
RxCUI 6135
Orange Book
A075319
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": "71335-0439_ae8e3f89-1b77-4934-9252-64d9888d13fd",
"productndc": "71335-0439",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "075319",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "Jun 15, 1999"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "KETOCONAZOLE",
"proprietary_name": "Ketoconazole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075319",
"marketing_category": "ANDA",
"nonproprietary_name": "Ketoconazole",
"start_marketing_date": "19990615",
"active_numerator_strength": "200"
}Related drugs
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