fluconazole

Product NDC
72189-149
11-digit product format
721890149
Labeler code
72189
Product ID
72189-149_2becff06-7cc2-1200-e063-6294a90ad1ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
direct rx
Application
ANDA208963
Marketing category
ANDA
Marketing start
2020-11-11
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
fluconazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUCONAZOLE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8VZV102JFY
Rxcui197698, 197699

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
72189-149-01fluconazole1 in 1 BLISTER PACKTABLET15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-149FLUCONAZOLE TABLET FLUCONAZOLE TABLET [DIRECT RX]5Current NDC, Legacy NDC, 1 package rows20250119_b3db505a-9677-6f5a-e053-2a95a90a13d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197698fluconazole 100 MG Oral TabletPSNb3db505a-9677-6f5a-e053-2a95a90a13d45
197699fluconazole 150 MG Oral TabletPSNb3db505a-9677-6f5a-e053-2a95a90a13d45
197698fluconazole 100 MG Oral TabletSCDb3db505a-9677-6f5a-e053-2a95a90a13d45
197699fluconazole 150 MG Oral TabletSCDb3db505a-9677-6f5a-e053-2a95a90a13d45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-149-01721890149011 TABLET in 1 BLISTER PACK (72189-149-01) 1 tablet2020-11-110000-00-00NoNoCurrent