FDA.reportPublic FDA data

Fluconazole

Product NDC
71205-650
11-digit product format
712050650
Labeler code
71205
Product ID
71205-650_2e7093ee-60d8-4b7f-b28d-f415a36ae086
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078423
Marketing category
ANDA
Marketing start
2021-04-22
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
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
FLUCONAZOLE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8VZV102JFY
Rxcui197698

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
71205-650-03Fluconazole3 in 1 BOTTLETABLET32
71205-650-10Fluconazole10 in 1 BOTTLETABLET102
71205-650-20Fluconazole20 in 1 BOTTLETABLET202
71205-650-30Fluconazole30 in 1 BOTTLETABLET302
71205-650-60Fluconazole60 in 1 BOTTLETABLET602
71205-650-90Fluconazole90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-650-03EA - Each71205-65008b1b044-06c6-4ef2-85aa-b42e09ba6c8d12023-04-07
71205-650-10EA - Each71205-650a680be56-9bdd-42a8-89a6-f3fd39cdd7a112022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-650FLUCONAZOLE TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 6 package rows20230211_b0aa9b22-5aef-459f-bb11-b193343eeb86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197698fluconazole 100 MG Oral TabletPSNb0aa9b22-5aef-459f-bb11-b193343eeb862
197698fluconazole 100 MG Oral TabletSCDb0aa9b22-5aef-459f-bb11-b193343eeb862

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-650-03712050650033 TABLET in 1 BOTTLE (71205-650-03) 3 tablet2023-02-09NoNoCurrent
71205-650-107120506501010 TABLET in 1 BOTTLE (71205-650-10) 10 tablet2022-03-290000-00-00NoNoCurrent
71205-650-207120506502020 TABLET in 1 BOTTLE (71205-650-20) 20 tablet2022-03-290000-00-00NoNoCurrent
71205-650-307120506503030 TABLET in 1 BOTTLE (71205-650-30) 30 tablet2022-03-290000-00-00NoNoCurrent
71205-650-607120506506060 TABLET in 1 BOTTLE (71205-650-60) 60 tablet2022-03-290000-00-00NoNoCurrent
71205-650-907120506509090 TABLET in 1 BOTTLE (71205-650-90) 90 tablet2022-03-290000-00-00NoNoCurrent