Fluconazole

Product NDC
71205-563
11-digit product format
712050563
Labeler code
71205
Product ID
71205-563_17807dbb-9edb-488a-b1ee-d2e4ecc7edb3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077731
Marketing category
ANDA
Marketing start
2008-10-07
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
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
71205-563-01712050563011 BLISTER PACK in 1 BAG (71205-563-01) / 1 TABLET in 1 BLISTER PACK1 blister pack2021-10-26NoNoHistorical
71205-563-02712050563022 BLISTER PACK in 1 BAG (71205-563-02) / 1 TABLET in 1 BLISTER PACK2 blister pack2021-05-10NoNoHistorical
71205-563-03712050563033 BLISTER PACK in 1 BAG (71205-563-03) / 1 TABLET in 1 BLISTER PACK3 blister pack2021-09-15NoNoHistorical
71205-563-04712050563044 BLISTER PACK in 1 BAG (71205-563-04) / 1 TABLET in 1 BLISTER PACK4 blister pack2023-01-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Fluconazole Tablets USP Rx onlyProficient Rx LP2023-01-01HUMAN PRESCRIPTION DRUG LABEL5