Fluconazole

Product NDC
68071-2906
11-digit product format
680712906
Labeler code
68071
Product ID
68071-2906_f06ec567-fcb0-2cf8-e053-2a95a90a9cc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077253
Marketing category
ANDA
Marketing start
2020-11-20
Marketing end
0000-00-00
Substance
FLUCONAZOLE
Active strength
150 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
2023-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
8VZV102JFYFLUCONAZOLE86386-73-4FLUCONAZOLE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2906-2680712906021 BLISTER PACK in 1 CARTON (68071-2906-2) > 1 TABLET in 1 BLISTER PACK1 blister pack2022-12-220000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Fluconazole TabletsNuCare Pharmaceuticals,Inc.2022-12-22HUMAN PRESCRIPTION DRUG LABEL1