Fluconazole

Product NDC
63187-096
11-digit product format
631870096
Labeler code
63187
Product ID
63187-096_5b625e97-73b5-4920-82e6-c80b864ecf4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-096-01EA - Each63187-09603c247d7-bb1d-46b1-a4d1-bfae83129eac12015-12-02
63187-096-02EA - Each63187-096fecc4133-2698-4d58-beeb-3e85033cfde912018-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE TABLET [PROFICIENT RX LP]2
FLUCONAZOLEACTIVE MOIETY8VZV102JFYFLUCONAZOLE TABLET [PROFICIENT RX LP]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JFLUCONAZOLE TABLET [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUCONAZOLE TABLET [PROFICIENT RX LP]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUCONAZOLE TABLET [PROFICIENT RX LP]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUCONAZOLE TABLET [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUCONAZOLE TABLET [PROFICIENT RX LP]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EFLUCONAZOLE TABLET [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-096FLUCONAZOLE TABLET [PROFICIENT RX LP]5Legacy NDC20200128_29ba8f57-f608-4a6d-b69e-ab3e07e5a7db.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-096-01631870096011 BLISTER PACK in 1 CARTON (63187-096-01) > 1 TABLET in 1 BLISTER PACK1 blister pack2018-11-010000-00-00NoNoCurrent
63187-096-02631870096021 BLISTER PACK in 1 CARTON (63187-096-02) > 2 TABLET in 1 BLISTER PACK1 blister pack2018-11-010000-00-00NoNoCurrent