FDA.reportPublic FDA data

Fluconazole

Product NDC
50090-3196
11-digit product format
500903196
Labeler code
50090
Product ID
50090-3196_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
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
50090-3196-02023-01-30C16284748780-1f386c649-e926-0266-e053-dadaa90a7c1aFluconazole Tablets, USP
50090-3196-12023-01-30C16284748780-1f386c649-e926-0266-e053-dadaa90a7c1aFluconazole Tablets, USP
50090-3196-32023-01-30C16284748780-1f386c649-e926-0266-e053-dadaa90a7c1aFluconazole Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3196-0Fluconazole28 in 1 BOTTLETABLET2810
50090-3196-1Fluconazole30 in 1 BOTTLETABLET3010
50090-3196-3Fluconazole2 in 1 BOTTLETABLET210

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3196-1EA - Each50090-31961fcd86ce-971e-46da-ab01-6416e7de40fb12019-05-02
50090-3196-3EA - Each50090-31961f44596b-9409-4de7-b325-c1d5ba557def12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3196FLUCONAZOLE TABLET [A-S MEDICATION SOLUTIONS]10Legacy NDC, 3 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
50090-3196-05009031960028 TABLET in 1 BOTTLE (50090-3196-0) 28 tablet2019-10-090000-00-00NoNoCurrent
50090-3196-15009031960130 TABLET in 1 BOTTLE (50090-3196-1) 30 tablet2017-10-200000-00-00NoNoCurrent
50090-3196-3500903196032 TABLET in 1 BOTTLE (50090-3196-3) 2 tablet2017-11-160000-00-00NoNoCurrent