Fluconazole

Product NDC
63629-1947
11-digit product format
636291947
Labeler code
63629
Product ID
63629-1947_e879c4b0-ece2-4139-a032-5df29633f917
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078423
Marketing category
ANDA
Marketing start
2011-03-07
Marketing end
2023-07-31
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
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
63629-1947-16362919470130 TABLET in 1 BOTTLE (63629-1947-1) 30 tablet2021-01-260000-00-00NoNoCurrent