Fluconazole

Product NDC
52343-087
11-digit product format
523430087
Labeler code
52343
Product ID
52343-087_a3a4f8db-a312-4c4d-b873-119ed4973bf1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
ACETRIS HEALTH, LLC
Application
ANDA077731
Marketing category
ANDA
Marketing start
2008-10-07
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52343-087-11EA - Each52343-0876b31ad20-d029-4b46-a2ac-63a21bacb60f12015-07-20
52343-087-22EA - Each52343-0871ca8c969-36df-4561-bed7-9359fa6bd24c12015-07-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52343-087-225234300872212 BLISTER PACK in 1 CARTON (52343-087-22) > 1 TABLET in 1 BLISTER PACK (52343-087-11) 12 blister pack2008-10-070000-00-00NoNoCurrent