FDA.reportPublic FDA data

Fluconazole

Product NDC
55111-145
11-digit product format
551110145
Labeler code
55111
Product ID
55111-145_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
150 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
FLUCONAZOLE150 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
55111-145-12Fluconazole12 in 1 CARTONTABLET1219
55111-145-71Fluconazole1 in 1 DOSE PACKTABLET119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-145-12EA - Each55111-145877bd8c0-59bb-425a-ba37-96e79521532a12014-12-01
55111-145-71EA - Each55111-1454099acd9-0b2d-4694-af73-32a5f3b2b86412015-10-02

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-145FLUCONAZOLE TABLET [DR. REDDY'S LABORATORIES LIMITED]18Current NDC, Legacy NDC, 2 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 TabletPSNb3db505a-9677-6f5a-e053-2a95a90a13d45
197699fluconazole 150 MG Oral TabletPSNa499c43e-0454-4a8c-a547-31e9816babdd5
197699fluconazole 150 MG Oral TabletPSNb3db505a-9677-6f5a-e053-2a95a90a13d45
197698fluconazole 100 MG Oral TabletSCDb3db505a-9677-6f5a-e053-2a95a90a13d45
197699fluconazole 150 MG Oral TabletSCDa499c43e-0454-4a8c-a547-31e9816babdd5
197699fluconazole 150 MG Oral TabletSCDb3db505a-9677-6f5a-e053-2a95a90a13d45
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
197699fluconazole 150 MG Oral TabletPSN1f3f1922-648e-1233-e063-6294a90a76f61
197699fluconazole 150 MG Oral TabletSCD1f3f1922-648e-1233-e063-6294a90a76f61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-145-125511101451212 DOSE PACK in 1 CARTON (55111-145-12) / 1 TABLET in 1 DOSE PACK (55111-145-71) 12 dose pack2014-06-200000-00-00NoNoCurrent
55111-145-71551110145711 in 1 DOSE PACKHistorical