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United States · US · US:51672-4026_3dd44662-95fb-0d34-e063-6294a90a5fbc
Ketoconazole
Orange BookUNIISPLATC D01AC08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeD01AC08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc11516724026010 BLISTER PACK in 1 BOX (51672-4026-0) / 10 TABLET in 1 BLISTER PACK
- ndc115167240261100 TABLET in 1 BOTTLE (51672-4026-1)
- ndc115167240262500 TABLET in 1 BOTTLE (51672-4026-2)
- ndc11516724026630 TABLET in 1 BOTTLE (51672-4026-6)
- ndc1151672402683 BLISTER PACK in 1 BOX (51672-4026-8) / 10 TABLET in 1 BLISTER PACK
- ndc1151672402695 BLISTER PACK in 1 BOX (51672-4026-9) / 10 TABLET in 1 BLISTER PACK
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": "51672-4026_3dd44662-95fb-0d34-e063-6294a90a5fbc",
"productndc": "51672-4026",
"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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