FDA.reportPublic FDA data

Fluconazole

Product NDC
50090-0869
11-digit product format
500900869
Labeler code
50090
Product ID
50090-0869_2a21911b-1d31-4c0b-b452-38a55a54db07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077253
Marketing category
ANDA
Marketing start
2006-01-25
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
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
50090-0869-02023-01-30C16284748780-1f386c649-f7a2-0266-e053-dadaa90a7c1aFluconazole Tablets
50090-0869-12023-01-30C16284748780-1f386c649-f7a2-0266-e053-dadaa90a7c1aFluconazole Tablets
50090-0869-22023-01-30C16284748780-1f386c649-f7a2-0266-e053-dadaa90a7c1aFluconazole Tablets
50090-0869-32023-01-30C16284748780-1f386c649-f7a2-0266-e053-dadaa90a7c1aFluconazole Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0869-0Fluconazole1 in 1 BLISTER PACKTABLET125
50090-0869-0Fluconazole1 in 1 BAGTABLET125
50090-0869-1Fluconazole12 in 1 BAGTABLET1225
50090-0869-1Fluconazole1 in 1 BLISTER PACKTABLET125
50090-0869-2Fluconazole1 in 1 BLISTER PACKTABLET125
50090-0869-2Fluconazole2 in 1 BAGTABLET225
50090-0869-3Fluconazole1 in 1 BLISTER PACKTABLET125
50090-0869-3Fluconazole4 in 1 BAGTABLET425

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0869-0EA - Each50090-0869978b2b26-e38a-4b15-ae2e-7f36c335f0fd12018-10-11
50090-0869-1EA - Each50090-086912a7d0d6-720c-4ab9-ad28-3b386819fe4712018-10-11
50090-0869-2EA - Each50090-08697f8369ea-7e6e-4944-9cec-85ba196f295b12018-10-11
50090-0869-3EA - Each50090-0869d3b63170-d079-4643-b18b-4ecec2a6e75b12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0869FLUCONAZOLE TABLET [A-S MEDICATION SOLUTIONS]25Legacy NDC, 8 package rows20210416_ec57e336-95b8-4a7d-adbb-bc839b670bde.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197699fluconazole 150 MG Oral TabletPSNec57e336-95b8-4a7d-adbb-bc839b670bde25
197699fluconazole 150 MG Oral TabletSCDec57e336-95b8-4a7d-adbb-bc839b670bde25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0869-0500900869001 BLISTER PACK in 1 BAG (50090-0869-0) > 1 TABLET in 1 BLISTER PACK1 blister pack2014-11-280000-00-00NoNoCurrent
50090-0869-15009008690112 BLISTER PACK in 1 BAG (50090-0869-1) > 1 TABLET in 1 BLISTER PACK12 blister pack2014-11-280000-00-00NoNoCurrent
50090-0869-2500900869022 BLISTER PACK in 1 BAG (50090-0869-2) > 1 TABLET in 1 BLISTER PACK2 blister pack2014-11-280000-00-00NoNoCurrent
50090-0869-3500900869034 BLISTER PACK in 1 BAG (50090-0869-3) > 1 TABLET in 1 BLISTER PACK4 blister pack2017-11-280000-00-00NoNoCurrent