fluconazole

Product NDC
63629-8054
11-digit product format
636298054
Labeler code
63629
Product ID
63629-8054_d511bd02-7ff8-45a3-9b0b-86b8da9f6384
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208963
Marketing category
ANDA
Marketing start
2017-04-06
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
2020-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8054-1636298054012 TABLET in 1 BOTTLE (63629-8054-1) 2 tablet2019-07-180000-00-00NoNoCurrent