Fluconazole

Product NDC
76413-161
11-digit product format
764130161
Labeler code
76413
Product ID
76413-161_3725bb37-4c2f-4af2-a83e-b8cfdb4fb117
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Central Texas Community Health Centers
Application
ANDA077731
Marketing category
ANDA
Marketing start
2008-10-07
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
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
74f0b828-cb79-42cb-bb6c-81c9f5bd2648Product name220250623
fe6bb120-ebc6-6290-9eab-e842fdb6c841Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76413-161-012020-01-31C16284748780-19d75b9d0-2572-f424-e053-dadaa90a57ceFluconazole Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76413-161-01Fluconazole1 in 1 BLISTER PACKTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76413-161FLUCONAZOLE TABLET [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]2Legacy NDC, 1 package rows20180616_5b95c88c-41c8-42a5-92f9-09611de09a76.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197699fluconazole 150 MG Oral TabletPSN5b95c88c-41c8-42a5-92f9-09611de09a762
197699fluconazole 150 MG Oral TabletSCD5b95c88c-41c8-42a5-92f9-09611de09a762

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76413-161-01764130161011 in 1 BLISTER PACKHistorical