FDA.reportPublic FDA data

Fluconazole

Product NDC
68462-101
11-digit product format
684620101
Labeler code
68462
Product ID
68462-101_639b832d-b798-4efb-8db0-e64b8ba81574
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA077253
Marketing category
ANDA
Marketing start
2006-01-25
Substance
FLUCONAZOLE
Active strength
50 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluconazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUCONAZOLE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8VZV102JFY
Rxcui197698, 197699, 197700, 197701

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
68462-101-10Fluconazole1000 in 1 BOTTLETABLET100023
68462-101-30Fluconazole30 in 1 BOTTLETABLET3023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-101-30EA - Each68462-10149d606a2-4d25-439d-83cd-dd16285dc0a212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA]10
FLUCONAZOLEACTIVE MOIETY8VZV102JFYFLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA]10
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JFLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA]10
POVIDONESINACTIVE INGREDIENTFZ989GH94EFLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-101FLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA]22Current NDC, Legacy NDC, 2 package rows20240405_3da5f41d-5200-45ac-b89d-00881237ec85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197698fluconazole 100 MG Oral TabletPSN3da5f41d-5200-45ac-b89d-00881237ec8523
197699fluconazole 150 MG Oral TabletPSN3da5f41d-5200-45ac-b89d-00881237ec8523
197700fluconazole 200 MG Oral TabletPSN3da5f41d-5200-45ac-b89d-00881237ec8523
197701fluconazole 50 MG Oral TabletPSN3da5f41d-5200-45ac-b89d-00881237ec8523
197698fluconazole 100 MG Oral TabletSCD3da5f41d-5200-45ac-b89d-00881237ec8523
197699fluconazole 150 MG Oral TabletSCD3da5f41d-5200-45ac-b89d-00881237ec8523
197700fluconazole 200 MG Oral TabletSCD3da5f41d-5200-45ac-b89d-00881237ec8523
197701fluconazole 50 MG Oral TabletSCD3da5f41d-5200-45ac-b89d-00881237ec8523

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-101-10684620101101000 TABLET in 1 BOTTLE (68462-101-10) 1000 tablet2006-01-250000-00-00NoNoCurrent
68462-101-306846201013030 TABLET in 1 BOTTLE (68462-101-30) 30 tablet2006-01-250000-00-00NoNoCurrent