Fluconazole

Product NDC
63629-8971
11-digit product format
636298971
Labeler code
63629
Product ID
63629-8971_3ab630ff-1a9b-46ff-87a4-8cb37eba7b07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078423
Marketing category
ANDA
Marketing start
2021-04-22
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 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8971-1EA - Each63629-89711e548544-1c4c-4f5f-96f5-2b1b55f7ce7212022-03-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8971-16362989710112 TABLET in 1 BOTTLE (63629-8971-1) 12 tablet2021-12-060000-00-00NoNoCurrent