FDA.reportPublic FDA data

Fluconazole

Product NDC
50090-6842
11-digit product format
500906842
Labeler code
50090
Product ID
50090-6842_8bc8e604-0cda-47c0-a195-6818eb6d9642
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077731
Marketing category
ANDA
Marketing start
2008-10-07
Substance
FLUCONAZOLE
Active strength
150 mg/1
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluconazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUCONAZOLE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8VZV102JFY
Rxcui197699

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
74f0b828-cb79-42cb-bb6c-81c9f5bd2648Product name220250623
fe6bb120-ebc6-6290-9eab-e842fdb6c841Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6842-0Fluconazole1 in 1 BLISTER PACKTABLET111
50090-6842-0Fluconazole1 in 1 CARTONTABLET111
50090-6842-1Fluconazole12 in 1 CARTONTABLET1211
50090-6842-1Fluconazole1 in 1 BLISTER PACKTABLET111
50090-6842-2Fluconazole2 in 1 CARTONTABLET211
50090-6842-2Fluconazole1 in 1 BLISTER PACKTABLET111
50090-6842-3Fluconazole1 in 1 BLISTER PACKTABLET111
50090-6842-3Fluconazole4 in 1 CARTONTABLET411

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6842-0EA - Each50090-68421d579b53-2c61-4c04-9e05-25981f4161d712024-01-04
50090-6842-1EA - Each50090-68424d1581cc-4550-4f65-82a4-551846c7ace012024-01-04
50090-6842-2EA - Each50090-6842fb1aba5b-6fbe-4908-9f1c-7b33ac48036b12024-01-04
50090-6842-3EA - Each50090-68428b0ea8f6-8661-487b-a8b8-9e12b20bdec212024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6842FLUCONAZOLE TABLET [A-S MEDICATION SOLUTIONS]8Current NDC, 8 package rows20231207_f25f31a6-4bad-40fa-bced-695552e27afd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197699fluconazole 150 MG Oral TabletPSNf25f31a6-4bad-40fa-bced-695552e27afd11
197699fluconazole 150 MG Oral TabletSCDf25f31a6-4bad-40fa-bced-695552e27afd11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6842-0500906842001 BLISTER PACK in 1 CARTON (50090-6842-0) / 1 TABLET in 1 BLISTER PACK1 blister pack2023-11-28NoNoCurrent
50090-6842-15009068420112 BLISTER PACK in 1 CARTON (50090-6842-1) / 1 TABLET in 1 BLISTER PACK12 blister pack2023-11-28NoNoCurrent
50090-6842-2500906842022 BLISTER PACK in 1 CARTON (50090-6842-2) / 1 TABLET in 1 BLISTER PACK2 blister pack2023-11-28NoNoCurrent
50090-6842-3500906842034 BLISTER PACK in 1 CARTON (50090-6842-3) / 1 TABLET in 1 BLISTER PACK4 blister pack2023-11-28NoNoCurrent