fluconazole

Product NDC
50090-4864
11-digit product format
500904864
Labeler code
50090
Product ID
50090-4864_c94c73b4-d7c2-422a-8429-2051313dbbee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208963
Marketing category
ANDA
Marketing start
2017-04-06
Marketing end
0000-00-00
Substance
FLUCONAZOLE
Active strength
200 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
50090-4864-12023-01-30C16284748780-1f386c649-a3ed-0266-e053-dadaa90a7c1aFluconazole Tablets, USP Rx only
50090-4864-32023-01-30C16284748780-1f386c649-a3ed-0266-e053-dadaa90a7c1aFluconazole Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4864-1fluconazole30 in 1 BOTTLETABLET303
50090-4864-3fluconazole2 in 1 BOTTLETABLET23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4864FLUCONAZOLE TABLET [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20210417_7961c029-746c-48c3-888b-8f8344102873.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197700fluconazole 200 MG Oral TabletPSN7961c029-746c-48c3-888b-8f83441028733
197700fluconazole 200 MG Oral TabletSCD7961c029-746c-48c3-888b-8f83441028733

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4864-15009048640130 TABLET in 1 BOTTLE (50090-4864-1) 30 tablet2020-01-230000-00-00NoNoCurrent
50090-4864-3500904864032 TABLET in 1 BOTTLE (50090-4864-3) 2 tablet2020-01-230000-00-00NoNoCurrent