Fluconazole

Product NDC
68071-2347
11-digit product format
680712347
Labeler code
68071
Product ID
68071-2347_bada7183-d920-9d63-e053-2a95a90a5dd5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077253
Marketing category
ANDA
Marketing start
2006-01-25
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2347-12023-01-30C16284748780-1f386c64a-2c89-0266-e053-dadaa90a7c1abadab396-c79e-0935-e053-2995a90a3776

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2347FLUCONAZOLE TABLET [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC20210210_badab396-c79e-0935-e053-2995a90a3776.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2347-1680712347011 TABLET in 1 BLISTER PACK (68071-2347-1) 1 tablet2021-02-080000-00-00NoNoCurrent