Fluconazole

Product NDC
50090-3196
11-digit product format
500903196
Labeler code
50090
Product ID
50090-3196_34c86f59-b6a8-438b-9b28-0a388d5c4487
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078423
Marketing category
ANDA
Marketing start
2011-03-07
Marketing end
0000-00-00
Substance
FLUCONAZOLE
Active strength
200 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
2022-12-31
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
50090-3196-05009031960028 TABLET in 1 BOTTLE (50090-3196-0) 28 tablet2019-10-090000-00-00NoNoCurrent
50090-3196-15009031960130 TABLET in 1 BOTTLE (50090-3196-1) 30 tablet2017-10-200000-00-00NoNoCurrent
50090-3196-3500903196032 TABLET in 1 BOTTLE (50090-3196-3) 2 tablet2017-11-160000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Fluconazole Tablets, USPA-S Medication Solutions2021-08-06HUMAN PRESCRIPTION DRUG LABEL10