ketoconazole

Product NDC
71335-2943
11-digit product format
713352943
Labeler code
71335
Product ID
71335-2943_77c68629-b9d4-45d7-bffb-5d3cbfdbb7fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketoconazole
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA091550
Marketing category
ANDA
Marketing start
2011-08-30
Substance
KETOCONAZOLE
Active strength
2 g/100g
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
71335-2943-1713352943011 CANISTER in 1 CARTON (71335-2943-1) / 100 g in 1 CANISTER1 canister2025-10-24NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ketoconazole - Bryant Ranch PrepackBryant Ranch Prepack2025-10-24HUMAN PRESCRIPTION DRUG LABEL100