Fluconazole

Product NDC
68788-7959
11-digit product format
687887959
Labeler code
68788
Product ID
68788-7959_06db596c-7e10-481a-bf20-29421d05de9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc., USA
Application
ANDA077253
Marketing category
ANDA
Marketing start
2021-07-19
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
68788-7959-1EA - Each68788-79595c74e3bd-2d9e-45e8-bd7f-ab651b7fdf0212021-08-05
68788-7959-2EA - Each68788-795903b25d0d-2852-484f-ae8a-687fc261c30312021-08-05
68788-7959-8EA - Each68788-795958d91ff2-d95f-4be6-9b84-165fa503fa0112021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7959FLUCONAZOLE TABLET [PREFERRED PHARMACEUTICALS INC., USA]5Legacy NDC20250514_63208a8c-333a-4095-84b4-38655a5ed83c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7959-1687887959011 TABLET in 1 BLISTER PACK (68788-7959-1) 1 tablet2021-07-190000-00-00NoNoCurrent
68788-7959-2687887959022 TABLET in 1 BLISTER PACK (68788-7959-2) 2 tablet2021-07-190000-00-00NoNoCurrent
68788-7959-86878879590812 TABLET in 1 BLISTER PACK (68788-7959-8) 12 tablet2021-07-190000-00-00NoNoCurrent