Fluconazole

Product NDC
42852-003
11-digit product format
428520003
Labeler code
42852
Product ID
42852-003_c78e92fe-c381-4afa-b221-c03cc5e391d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Apothecary Shop Wholesale Inc.
Application
ANDA076077
Marketing category
ANDA
Marketing start
2011-07-01
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
42852-003-032019-10-29C16284748780-1960f7f55-d4c9-8e05-e053-dbdaa90a074aFLUCONAZOLE TABLETS
42852-003-062019-10-29C16284748780-1960f7f55-d4c9-8e05-e053-dbdaa90a074aFLUCONAZOLE TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42852-003-03Fluconazole30 in 1 BOTTLETABLET301
42852-003-06Fluconazole60 in 1 BOTTLETABLET601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FluconazoleACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.]1
FluconazoleACTIVE MOIETY8VZV102JFYFLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.]1
Aluminum OxideINACTIVE INGREDIENTLMI26O6933FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UFLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.]1
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.]1
FD&C Red NO. 40INACTIVE INGREDIENTWZB9127XOAFLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.]1
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XFLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJFLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.]1
TalcINACTIVE INGREDIENT7SEV7J4R1UFLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42852-003FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.]1Legacy NDC, 2 package rows20110718_5314ab7a-e750-4e6b-8ef2-e37f831e088b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197699fluconazole 150 MG Oral TabletPSN5314ab7a-e750-4e6b-8ef2-e37f831e088b1
197699fluconazole 150 MG Oral TabletSCD5314ab7a-e750-4e6b-8ef2-e37f831e088b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42852-003-034285200030330 in 1 BOTTLEHistorical
42852-003-064285200030660 in 1 BOTTLEHistorical