Fluconazole

Product NDC
63629-1948
11-digit product format
636291948
Labeler code
63629
Product ID
63629-1948_6d68cb01-90f5-4478-8dc6-a919d242bd85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078423
Marketing category
ANDA
Marketing start
2017-02-24
Marketing end
2023-07-31
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
0000-00-00
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
63629-1948-16362919480112 TABLET in 1 BOTTLE (63629-1948-1) 12 tablet2021-01-260000-00-00NoNoCurrent