Fluconazole

Product NDC
63629-7986
11-digit product format
636297986
Labeler code
63629
Product ID
63629-7986_721560ef-c4a9-4c29-af02-f8897b85292d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078423
Marketing category
ANDA
Marketing start
2017-02-24
Marketing end
2023-07-31
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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-7986-1EA - Each63629-79866dcd519e-8eb9-4bbb-afdd-5d4c9b9df36012019-06-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7986-1636297986011 TABLET in 1 BOTTLE (63629-7986-1) 1 tablet2019-04-080000-00-00NoNoCurrent