KETOCONAZOLE

Product NDC
72189-180
11-digit product format
721890180
Labeler code
72189
Product ID
72189-180_2be953af-ba6e-e430-e063-6294a90a9a1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
KETOCONAZOLE
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA075912
Marketing category
ANDA
Marketing start
2021-02-24
Substance
KETOCONAZOLE
Active strength
200 mg/1
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
R9400W927IKETOCONAZOLE65277-42-1KETOCONAZOLE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-180-07721890180077 TABLET in 1 BOTTLE (72189-180-07) 7 tablet2021-02-24NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
KetoconazoleDirect Rx2025-01-17HUMAN PRESCRIPTION DRUG LABEL2