Fluconazole

Product NDC
0172-5410
11-digit product format
001725410
Labeler code
0172
Product ID
0172-5410_27a18adf-4a27-479c-bd3c-a58938662ee1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA076077
Marketing category
ANDA
Marketing start
2004-07-29
Marketing end
2022-06-30
Substance
FLUCONAZOLE
Active strength
50 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
0172-5410-00EA - Each0172-54105ab5f249-570e-4c13-8734-ed9caf2fc6f512012-07-24
0172-5410-10EA - Each0172-5410d6174694-eb13-44f3-9829-dc3d5e12ac3412012-07-24
0172-5410-46EA - Each0172-5410df04fac0-a662-4a1b-a24c-2e628279c84512012-07-24
0172-5410-60EA - Each0172-5410ad0720e7-f540-40a6-be6c-0f958c300c8812012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0172-5410-460017254104630 TABLET in 1 BOTTLE (0172-5410-46) 30 tablet2004-07-292022-06-30NoNoCurrent