FDA.reportPublic FDA data

Fluconazole

Product NDC
63187-584
11-digit product format
631870584
Labeler code
63187
Product ID
63187-584_9d64967b-38cf-462f-b8c2-9f019a4f876f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
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
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
63187-584-01Fluconazole1 in 1 BLISTER PACKTABLET17
63187-584-02Fluconazole2 in 1 BLISTER PACKTABLET27
63187-584-03Fluconazole3 in 1 BLISTER PACKTABLET37
63187-584-04Fluconazole4 in 1 BLISTER PACKTABLET47

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-584FLUCONAZOLE TABLET [PROFICIENT RX LP]7Current NDC, Legacy NDC, 4 package rows20241115_4eaf5b04-c026-4a49-879f-2925b375f903.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197699fluconazole 150 MG Oral TabletPSN4eaf5b04-c026-4a49-879f-2925b375f9037
197699fluconazole 150 MG Oral TabletSCD4eaf5b04-c026-4a49-879f-2925b375f9037

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-584-01631870584011 TABLET in 1 BLISTER PACK (63187-584-01) 1 tablet2018-12-010000-00-00NoNoCurrent
63187-584-02631870584022 TABLET in 1 BLISTER PACK (63187-584-02) 2 tablet2019-10-310000-00-00NoNoCurrent
63187-584-03631870584033 TABLET in 1 BLISTER PACK (63187-584-03) 3 tablet2024-11-06NoNoCurrent
63187-584-04631870584044 TABLET in 1 BLISTER PACK (63187-584-04) 4 tablet2019-02-010000-00-00NoNoCurrent