FDA.reportPublic FDA data

Fluconazole

Product NDC
21695-193
11-digit product format
216950193
Labeler code
21695
Product ID
21695-193_8e80f9d8-2577-4fd9-a455-e6c6dc244c3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA077253
Marketing category
ANDA
Marketing start
2006-01-25
Marketing end
0000-00-00
Substance
FLUCONAZOLE
Active strength
150 mg/1
Pharmacologic classes
Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-193-012019-09-24C16284748780-1934fe258-482a-48b1-e053-8cdaa90a720aFluconazole Tablets USP
21695-193-022019-09-24C16284748780-1934fe258-482a-48b1-e053-8cdaa90a720aFluconazole Tablets USP
21695-193-122019-09-24C16284748780-1934fe258-482a-48b1-e053-8cdaa90a720aFluconazole Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-193-01Fluconazole1 in 1 BLISTER PACKTABLET11
21695-193-01Fluconazole1 in 1 CARTONTABLET11
21695-193-02Fluconazole2 in 1 CARTONTABLET21
21695-193-02Fluconazole1 in 1 BLISTER PACKTABLET11
21695-193-12Fluconazole1 in 1 BLISTER PACKTABLET11
21695-193-12Fluconazole12 in 1 CARTONTABLET121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-193-01EA - Each21695-19361eaa1a5-e245-43fb-b046-86528ba7754112012-07-24
21695-193-02EA - Each21695-193dc632f0d-33c2-4d46-b15e-cc5ec594f92c12012-07-24
21695-193-12EA - Each21695-193d2b4dc80-7809-410b-a78e-5f27fef8758512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]1
FLUCONAZOLEACTIVE MOIETY8VZV102JFYFLUCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JFLUCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EFLUCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-193FLUCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 6 package rows20101123_8e80f9d8-2577-4fd9-a455-e6c6dc244c3a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197698fluconazole 100 MG Oral TabletPSN8e80f9d8-2577-4fd9-a455-e6c6dc244c3a1
197699fluconazole 150 MG Oral TabletPSN8e80f9d8-2577-4fd9-a455-e6c6dc244c3a1
197700fluconazole 200 MG Oral TabletPSN8e80f9d8-2577-4fd9-a455-e6c6dc244c3a1
197698fluconazole 100 MG Oral TabletSCD8e80f9d8-2577-4fd9-a455-e6c6dc244c3a1
197699fluconazole 150 MG Oral TabletSCD8e80f9d8-2577-4fd9-a455-e6c6dc244c3a1
197700fluconazole 200 MG Oral TabletSCD8e80f9d8-2577-4fd9-a455-e6c6dc244c3a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-193-01216950193011 in 1 BLISTER PACKHistorical
21695-193-02216950193022 in 1 CARTONHistorical
21695-193-12216950193121 in 1 BLISTER PACKHistorical