fluconazole

Product NDC
50090-4426
11-digit product format
500904426
Labeler code
50090
Product ID
50090-4426_d181832e-6355-4dbd-8e2b-b3f9de90f74e
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
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
2021-12-31
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
50090-4426-02023-01-30C16284748780-1f386c64a-48f6-0266-e053-dadaa90a7c1aFluconazole Tablets, USP Rx only
50090-4426-12023-01-30C16284748780-1f386c64a-48f6-0266-e053-dadaa90a7c1aFluconazole Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4426-0fluconazole12 in 1 CARTONTABLET121
50090-4426-0fluconazole1 in 1 BLISTER PACKTABLET11
50090-4426-1fluconazole1 in 1 BLISTER PACKTABLET11
50090-4426-1fluconazole12 in 1 CARTONTABLET121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4426FLUCONAZOLE TABLET [A-S MEDICATION SOLUTIONS]1Legacy NDC, 4 package rows20200710_2b59df21-160c-4f59-8129-526e865e24ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197699fluconazole 150 MG Oral TabletPSN2b59df21-160c-4f59-8129-526e865e24ad1
197699fluconazole 150 MG Oral TabletSCD2b59df21-160c-4f59-8129-526e865e24ad1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4426-05009044260012 BLISTER PACK in 1 CARTON (50090-4426-0) > 1 TABLET in 1 BLISTER PACK12 blister pack2019-07-190000-00-00NoNoCurrent
50090-4426-15009044260112 BLISTER PACK in 1 CARTON (50090-4426-1) > 1 TABLET in 1 BLISTER PACK12 blister pack2019-07-190000-00-00NoNoCurrent