Fluconazole

Product NDC
68071-3768
11-digit product format
680713768
Labeler code
68071
Product ID
68071-3768_2b9b049f-8ed3-0535-e063-6394a90afc7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA077731
Marketing category
ANDA
Marketing start
2008-10-07
Substance
FLUCONAZOLE
Active strength
100 mg/1
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 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
8VZV102JFYFLUCONAZOLE86386-73-4FLUCONAZOLE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3768-3680713768033 TABLET in 1 BOTTLE (68071-3768-3) 3 tablet2025-01-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Fluconazole Tablets USP Rx onlyNuCare Pharmaceuticals, Inc.2025-01-13HUMAN PRESCRIPTION DRUG LABEL1