FDA.reportPublic FDA data

Fluconazole

Product NDC
55111-146
11-digit product format
551110146
Labeler code
55111
Product ID
55111-146_69e67aa4-a859-7ab0-79df-d9bf8489998d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA076658
Marketing category
ANDA
Marketing start
2014-06-20
Substance
FLUCONAZOLE
Active strength
200 mg/1
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluconazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUCONAZOLE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8VZV102JFY
Rxcui197698, 197699, 197700, 197701

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
74f0b828-cb79-42cb-bb6c-81c9f5bd2648Product name220250623
fe6bb120-ebc6-6290-9eab-e842fdb6c841Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-146-01Fluconazole100 in 1 BOTTLETABLET10019
55111-146-05Fluconazole500 in 1 BOTTLETABLET50019
55111-146-30Fluconazole30 in 1 BOTTLETABLET3019
55111-146-78Fluconazole10 in 1 CARTONTABLET1019
55111-146-79Fluconazole10 in 1 DOSE PACKTABLET1019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-146-01EA - Each55111-146d9737376-8d37-4a4e-8bce-8c847fb083dc12015-01-05
55111-146-30EA - Each55111-1463ae3001c-2e73-43f9-acd5-45b2962394e512015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FluconazoleACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE TABLET [DR. REDDY'S LABORATORIES LIMITED]4
FluconazoleACTIVE MOIETY8VZV102JFYFLUCONAZOLE TABLET [DR. REDDY'S LABORATORIES LIMITED]4
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JFLUCONAZOLE TABLET [DR. REDDY'S LABORATORIES LIMITED]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUCONAZOLE TABLET [DR. REDDY'S LABORATORIES LIMITED]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FLUCONAZOLE TABLET [DR. REDDY'S LABORATORIES LIMITED]4
magnesium stearateINACTIVE INGREDIENT70097M6I30FLUCONAZOLE TABLET [DR. REDDY'S LABORATORIES LIMITED]4
povidoneINACTIVE INGREDIENTFZ989GH94EFLUCONAZOLE TABLET [DR. REDDY'S LABORATORIES LIMITED]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FLUCONAZOLE TABLET [DR. REDDY'S LABORATORIES LIMITED]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUCONAZOLE TABLET [DR. REDDY'S LABORATORIES LIMITED]4
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE TABLET [MAJOR PHARMACEUTICALS]1
FLUCONAZOLEACTIVE MOIETY8VZV102JFYFLUCONAZOLE TABLET [MAJOR PHARMACEUTICALS]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JFLUCONAZOLE TABLET [MAJOR PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUCONAZOLE TABLET [MAJOR PHARMACEUTICALS]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FLUCONAZOLE TABLET [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUCONAZOLE TABLET [MAJOR PHARMACEUTICALS]1
POVIDONE K12INACTIVE INGREDIENT333AG72FWJFLUCONAZOLE TABLET [MAJOR PHARMACEUTICALS]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FLUCONAZOLE TABLET [MAJOR PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUCONAZOLE TABLET [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-146FLUCONAZOLE TABLET [DR. REDDY'S LABORATORIES LIMITED]18Current NDC, Legacy NDC, 5 package rows20240927_d7fa1d79-4cd3-4a55-b74b-b31e82e616a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197698fluconazole 100 MG Oral TabletPSNd7fa1d79-4cd3-4a55-b74b-b31e82e616a319
197699fluconazole 150 MG Oral TabletPSNd7fa1d79-4cd3-4a55-b74b-b31e82e616a319
197700fluconazole 200 MG Oral TabletPSNd7fa1d79-4cd3-4a55-b74b-b31e82e616a319
197701fluconazole 50 MG Oral TabletPSNd7fa1d79-4cd3-4a55-b74b-b31e82e616a319
197698fluconazole 100 MG Oral TabletSCDd7fa1d79-4cd3-4a55-b74b-b31e82e616a319
197699fluconazole 150 MG Oral TabletSCDd7fa1d79-4cd3-4a55-b74b-b31e82e616a319
197700fluconazole 200 MG Oral TabletSCDd7fa1d79-4cd3-4a55-b74b-b31e82e616a319
197701fluconazole 50 MG Oral TabletSCDd7fa1d79-4cd3-4a55-b74b-b31e82e616a319
197698fluconazole 100 MG Oral TabletPSN13184b13-e252-4b4d-a3e2-cfc4ad3d55b78
197700fluconazole 200 MG Oral TabletPSN13184b13-e252-4b4d-a3e2-cfc4ad3d55b78
197698fluconazole 100 MG Oral TabletSCD13184b13-e252-4b4d-a3e2-cfc4ad3d55b78
197700fluconazole 200 MG Oral TabletSCD13184b13-e252-4b4d-a3e2-cfc4ad3d55b78
197698fluconazole 100 MG Oral TabletPSN8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2
197699fluconazole 150 MG Oral TabletPSN8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2
197700fluconazole 200 MG Oral TabletPSN8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2
197701fluconazole 50 MG Oral TabletPSN8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2
197698fluconazole 100 MG Oral TabletSCD8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2
197699fluconazole 150 MG Oral TabletSCD8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2
197700fluconazole 200 MG Oral TabletSCD8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2
197701fluconazole 50 MG Oral TabletSCD8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-146-0155111014601100 TABLET in 1 BOTTLE (55111-146-01) 100 tablet2014-06-200000-00-00NoNoCurrent
55111-146-0555111014605500 TABLET in 1 BOTTLE (55111-146-05) 500 tablet2014-06-200000-00-00NoNoCurrent
55111-146-305511101463030 TABLET in 1 BOTTLE (55111-146-30) 30 tablet2014-06-200000-00-00NoNoCurrent
55111-146-785511101467810 DOSE PACK in 1 CARTON (55111-146-78) / 10 TABLET in 1 DOSE PACK (55111-146-79) 10 dose pack2014-06-200000-00-00NoNoCurrent
55111-146-795511101467910 in 1 DOSE PACKHistorical