Fluconazole

Product NDC
63629-8749
11-digit product format
636298749
Labeler code
63629
Product ID
63629-8749_3ec5fa31-8d05-4573-98fe-588dd694f3f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076077
Marketing category
ANDA
Marketing start
2004-07-29
Marketing end
2022-06-30
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
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
63629-8749-1EA - Each63629-874910acede6-3cda-4e22-a69e-1d9c6667b3e612021-10-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8749-16362987490130 TABLET in 1 BOTTLE (63629-8749-1) 30 tablet2021-08-202022-06-30NoNoCurrent