Fluconazole

Product NDC
50090-3899
11-digit product format
500903899
Labeler code
50090
Product ID
50090-3899_ba2d176f-978d-46bf-8076-3ebdb8e4c3d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078423
Marketing category
ANDA
Marketing start
2017-02-24
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 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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
50090-3899-0500903899001 BLISTER PACK in 1 CARTON (50090-3899-0) > 1 TABLET in 1 BLISTER PACK1 blister pack2018-12-040000-00-00NoNoCurrent
50090-3899-2500903899022 TABLET in 1 BOTTLE, PLASTIC (50090-3899-2) 2 tablet2017-02-240000-00-00NoNoCurrent
50090-3899-3500903899034 TABLET in 1 BOTTLE, PLASTIC (50090-3899-3) 4 tablet2017-02-240000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Fluconazole Tablets, USPA-S Medication Solutions2019-04-30HUMAN PRESCRIPTION DRUG LABEL5