Fluconazole

Product NDC
33261-229
11-digit product format
332610229
Labeler code
33261
Product ID
33261-229_47349194-fbe8-4176-86f2-67454764c301
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA076077
Marketing category
ANDA
Marketing start
2004-07-29
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 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-229-06Fluconazole6 in 1 BOTTLE, PLASTICTABLET61
33261-229-07Fluconazole7 in 1 BOTTLE, PLASTICTABLET71
33261-229-31Fluconazole3 in 1 BOTTLE, PLASTICTABLET31
33261-229-40Fluconazole40 in 1 BOTTLE, PLASTICTABLET401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-229-06EA - Each33261-22965367f8f-62b5-4df2-97b0-fae93cd9294c12015-10-02
33261-229-07EA - Each33261-2294ea21e8d-5a67-49c4-8f42-294dbabdeb4f12015-10-02
33261-229-31EA - Each33261-2296f1bea24-4b90-4791-918e-42c0eb6126d412015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
FLUCONAZOLEACTIVE MOIETY8VZV102JFYFLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UFLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-229FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20140107_f5f31f75-2be5-4c12-a8f0-1f1f5ac05a3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197700fluconazole 200 MG Oral TabletPSNf5f31f75-2be5-4c12-a8f0-1f1f5ac05a3e1
197700fluconazole 200 MG Oral TabletSCDf5f31f75-2be5-4c12-a8f0-1f1f5ac05a3e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-229-06332610229066 in 1 BOTTLE, PLASTICHistorical
33261-229-07332610229077 in 1 BOTTLE, PLASTICHistorical
33261-229-31332610229313 in 1 BOTTLE, PLASTICHistorical
33261-229-403326102294040 in 1 BOTTLE, PLASTICHistorical