Fluconazole

Product NDC
55154-3400
11-digit product format
551543400
Labeler code
55154
Product ID
55154-3400_021021a2-991b-48bc-b217-aa08eb530829
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA076658
Marketing category
ANDA
Marketing start
2015-06-25
Substance
FLUCONAZOLE
Active strength
100 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
FLUCONAZOLE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8VZV102JFY
Rxcui197698, 197700

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
55154-3400-0Fluconazole10 in 1 BAGTABLET1012
55154-3400-0Fluconazole1 in 1 BLISTER PACKTABLET112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-3400FLUCONAZOLE TABLET [CARDINAL HEALTH 107, LLC]9Current NDC, Legacy NDC, 2 package rows20250104_f1bfba3a-5b18-41c0-9084-b1f26bb93ef2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197698fluconazole 100 MG Oral TabletPSNf1bfba3a-5b18-41c0-9084-b1f26bb93ef212
197700fluconazole 200 MG Oral TabletPSNf1bfba3a-5b18-41c0-9084-b1f26bb93ef212
197698fluconazole 100 MG Oral TabletSCDf1bfba3a-5b18-41c0-9084-b1f26bb93ef212
197700fluconazole 200 MG Oral TabletSCDf1bfba3a-5b18-41c0-9084-b1f26bb93ef212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-3400-05515434000010 BLISTER PACK in 1 BAG (55154-3400-0) / 1 TABLET in 1 BLISTER PACK10 blister pack2015-06-250000-00-00NoNoCurrent