Fluconazole

Product NDC
50436-5128
11-digit product format
504365128
Labeler code
50436
Product ID
50436-5128_cdf30efe-780c-4989-a99f-25d0a0f3fdd9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
NDA019949
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1990-01-29
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
50436-5128-12020-01-31C16284748780-19d75b9cf-e97e-f424-e053-dadaa90a57ceFLUCONAZOLE Fluconazole Tablets Fluconazole for Oral Suspension

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-5128-1Fluconazole1 in 1 CARTONTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-5128FLUCONAZOLE TABLET [UNIT DOSE SERVICES]2Legacy NDC, 1 package rows20160526_1a954488-d807-4adb-8990-0dde8d178fa9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197699fluconazole 150 MG Oral TabletPSN1a954488-d807-4adb-8990-0dde8d178fa92
197699fluconazole 150 MG Oral TabletSCD1a954488-d807-4adb-8990-0dde8d178fa92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-5128-1504365128011 in 1 CARTONHistorical