Fluconazole

Product NDC
50090-3194
11-digit product format
500903194
Labeler code
50090
Product ID
50090-3194_34c86f59-b6a8-438b-9b28-0a388d5c4487
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078423
Marketing category
ANDA
Marketing start
2011-03-07
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 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

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
50090-3194-02023-01-30C16284748780-1f386c649-e926-0266-e053-dadaa90a7c1aFluconazole Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3194-0Fluconazole7 in 1 BOTTLETABLET710

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3194-0EA - Each50090-3194f3dd2c47-1982-48f4-b474-9d4b0e9e097c12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3194FLUCONAZOLE TABLET [A-S MEDICATION SOLUTIONS]10Legacy NDC, 1 package rows20210808_4021916f-3063-4a89-a7a1-fe0705e36e22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197698fluconazole 100 MG Oral TabletPSN4021916f-3063-4a89-a7a1-fe0705e36e2210
197700fluconazole 200 MG Oral TabletPSN4021916f-3063-4a89-a7a1-fe0705e36e2210
197698fluconazole 100 MG Oral TabletSCD4021916f-3063-4a89-a7a1-fe0705e36e2210
197700fluconazole 200 MG Oral TabletSCD4021916f-3063-4a89-a7a1-fe0705e36e2210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3194-0500903194007 TABLET in 1 BOTTLE (50090-3194-0) 7 tablet2017-10-190000-00-00NoNoCurrent