Fluconazole

Product NDC
61919-380
11-digit product format
619190380
Labeler code
61919
Product ID
61919-380_da56d70d-707f-a820-e053-2995a90afc12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA076658
Marketing category
ANDA
Marketing start
2017-11-01
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

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
61919-380-03Fluconazole3 in 1 BOTTLETABLET36

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYDIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
FLUCONAZOLEACTIVE MOIETY8VZV102JFYDIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JDIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
magnesium stearateINACTIVE INGREDIENT70097M6I30DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
povidoneINACTIVE INGREDIENTFZ989GH94EDIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-380FLUCONAZOLE TABLET [DIRECT RX]6Legacy NDC, 1 package rows20240110_69f199fa-bb92-4837-8b12-427a1c71f622.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197700fluconazole 200 MG Oral TabletPSN69f199fa-bb92-4837-8b12-427a1c71f6226
197700fluconazole 200 MG Oral TabletSCD69f199fa-bb92-4837-8b12-427a1c71f6226

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-380-03619190380033 TABLET in 1 BOTTLE (61919-380-03) 3 tablet2017-11-010000-00-00NoNoCurrent