Fluconazole

Product NDC
61919-333
11-digit product format
619190333
Labeler code
61919
Product ID
61919-333_9c9402dc-ee6d-6c1f-e053-2995a90adabd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Direct RX
Application
ANDA077253
Marketing category
ANDA
Marketing start
2016-02-12
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-333-01EA - Each61919-333ce55b301-a728-4ff4-8d03-7f9fb95c7e9812016-09-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-333-01619190333011 TABLET in 1 BOTTLE (61919-333-01) 1 tablet2016-02-120000-00-00NoNoCurrent