Fluconazole

Product NDC
43063-326
11-digit product format
430630326
Labeler code
43063
Product ID
43063-326_dd41ee89-33e6-1081-e053-2995a90ab815
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA077253
Marketing category
ANDA
Marketing start
2006-01-25
Marketing end
0000-00-00
Substance
FLUCONAZOLE
Active strength
100 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
43063-326-10EA - Each43063-326d9d5d553-6d9e-4726-8fb0-c5731eaa2efd12013-05-02
43063-326-14EA - Each43063-326b3ba23ef-783c-4820-9b7a-4f69daaced9712012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-326-104306303261010 TABLET in 1 BOTTLE, PLASTIC (43063-326-10) 10 tablet2011-05-200000-00-00NoNoCurrent
43063-326-144306303261414 TABLET in 1 BOTTLE, PLASTIC (43063-326-14) 14 tablet2011-05-200000-00-00NoNoCurrent