Fluconazole

Product NDC
82982-070
11-digit product format
829820070
Labeler code
82982
Product ID
82982-070_198ba216-39a2-3d98-e063-6394a90a9f0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Pharmasource Meds, LLC
Application
ANDA077731
Marketing category
ANDA
Marketing start
2023-06-13
Marketing end
2027-06-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluconazole

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
82982-070-02Fluconazole2 in 1 BLISTER PACKTABLET22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82982-070FLUCONAZOLE TABLET [PHARMASOURCE MEDS, LLC]2Current NDC, 1 package rows20240601_fe0cc56d-c0b6-f859-e053-6294a90ad932.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197699fluconazole 150 MG Oral TabletPSNfe0cc56d-c0b6-f859-e053-6294a90ad9322
197699fluconazole 150 MG Oral TabletSCDfe0cc56d-c0b6-f859-e053-6294a90ad9322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82982-070-02829820070022 TABLET in 1 BLISTER PACK (82982-070-02) 2 tablet2023-06-132027-06-30NoNoHistorical