FDA.reportPublic FDA data

Fluconazole

Product NDC
71205-796
11-digit product format
712050796
Labeler code
71205
Product ID
71205-796_fa2fa2f8-f3a6-4bc0-943c-03dabd0f1581
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077253
Marketing category
ANDA
Marketing start
2020-11-20
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
71205-796-01Fluconazole1 in 1 BAGTABLET11
71205-796-01Fluconazole1 in 1 BLISTER PACKTABLET11
71205-796-02Fluconazole1 in 1 BLISTER PACKTABLET11
71205-796-02Fluconazole2 in 1 BAGTABLET21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-796-01EA - Each71205-796eb86a965-9ebc-451d-a181-a70db01e5d8a12023-08-08
71205-796-02EA - Each71205-796d8678a2b-0670-4a34-bff0-f508d4ba1c3012023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-796FLUCONAZOLE TABLET [PROFICIENT RX LP]1Current NDC, 4 package rows20230506_fa2fa2f8-f3a6-4bc0-943c-03dabd0f1581.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197699fluconazole 150 MG Oral TabletPSNfa2fa2f8-f3a6-4bc0-943c-03dabd0f15811
197699fluconazole 150 MG Oral TabletSCDfa2fa2f8-f3a6-4bc0-943c-03dabd0f15811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-796-01712050796011 BLISTER PACK in 1 BAG (71205-796-01) / 1 TABLET in 1 BLISTER PACK1 blister pack2023-04-28NoNoCurrent
71205-796-02712050796022 BLISTER PACK in 1 BAG (71205-796-02) / 1 TABLET in 1 BLISTER PACK2 blister pack2023-04-28NoNoCurrent