FLUCONAZOLE

Product NDC
61919-282
11-digit product format
619190282
Labeler code
61919
Product ID
61919-282_edbb2edf-03ed-487c-8c35-728a35c0a032
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUCONAZOLE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA076077
Marketing category
ANDA
Marketing start
2014-01-01
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
61919-282-122020-01-31C16284748780-19d75b9d1-21db-f424-e053-dadaa90a57ceFLUCONAZOLE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-282-01FLUCONAZOLE1 in 1 BLISTER PACKTABLET12
61919-282-12FLUCONAZOLE12 in 1 PACKAGETABLET122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-282-01EA - Each61919-28209a11c11-6110-4ecc-b4ef-404c1113fcee12015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE TABLET [DIRECT RX]2
FLUCONAZOLEACTIVE MOIETY8VZV102JFYFLUCONAZOLE TABLET [DIRECT RX]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933FLUCONAZOLE TABLET [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUCONAZOLE TABLET [DIRECT RX]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUCONAZOLE TABLET [DIRECT RX]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUCONAZOLE TABLET [DIRECT RX]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLUCONAZOLE TABLET [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUCONAZOLE TABLET [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUCONAZOLE TABLET [DIRECT RX]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUCONAZOLE TABLET [DIRECT RX]2
TALCINACTIVE INGREDIENT7SEV7J4R1UFLUCONAZOLE TABLET [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-282FLUCONAZOLE TABLET [DIRECT RX]2Legacy NDC, 2 package rows20150625_f70c14ff-4bdc-4c1f-a118-ff3e85a04302.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197699fluconazole 150 MG Oral TabletPSNf70c14ff-4bdc-4c1f-a118-ff3e85a043022
197699fluconazole 150 MG Oral TabletSCDf70c14ff-4bdc-4c1f-a118-ff3e85a043022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-282-01619190282011 in 1 BLISTER PACKHistorical
61919-282-126191902821212 in 1 PACKAGEHistorical