Fluconazole

Product NDC
63187-878
11-digit product format
631870878
Labeler code
63187
Product ID
63187-878_05e11a44-c072-4969-9175-1caa92458ad7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077253
Marketing category
ANDA
Marketing start
2006-01-25
Substance
FLUCONAZOLE
Active strength
200 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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
8VZV102JFYFLUCONAZOLE86386-73-4FLUCONAZOLE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63187-878-01631870878011 TABLET in 1 BOTTLE (63187-878-01) 1 tablet2017-08-01NoNoHistorical
63187-878-02631870878022 TABLET in 1 BOTTLE (63187-878-02) 2 tablet2017-08-01NoNoHistorical
63187-878-306318708783030 TABLET in 1 BOTTLE (63187-878-30) 30 tablet2017-08-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Fluconazole Tablets USP, for oral use rx onlyProficient Rx LP2022-08-01HUMAN PRESCRIPTION DRUG LABEL4