Fluconazole

Product NDC
63187-878
11-digit product format
631870878
Labeler code
63187
Product ID
63187-878_05e11a44-c072-4969-9175-1caa92458ad7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077253
Marketing category
ANDA
Marketing start
2006-01-25
Substance
FLUCONAZOLE
Active strength
200 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
FLUCONAZOLE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8VZV102JFY
Rxcui197700

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
63187-878-01Fluconazole01 in 1 BOTTLETABLET014
63187-878-02Fluconazole02 in 1 BOTTLETABLET024
63187-878-30Fluconazole30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-878-30EA - Each63187-878235fe76c-d6ae-4e3b-b8b8-28644fff0aa312017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-878FLUCONAZOLE TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20220811_fbb1bda3-f733-4404-9c9d-46c418700c03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197700fluconazole 200 MG Oral TabletPSNfbb1bda3-f733-4404-9c9d-46c418700c034
197700fluconazole 200 MG Oral TabletSCDfbb1bda3-f733-4404-9c9d-46c418700c034

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-878-01631870878011 TABLET in 1 BOTTLE (63187-878-01) 1 tablet2017-08-010000-00-00NoNoCurrent
63187-878-02631870878022 TABLET in 1 BOTTLE (63187-878-02) 2 tablet2017-08-010000-00-00NoNoCurrent
63187-878-306318708783030 TABLET in 1 BOTTLE (63187-878-30) 30 tablet2017-08-010000-00-00NoNoCurrent