FDA.reportPublic FDA data

NDC 55111-145-71 - Fluconazole

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
55111-145
Requested NDC
55111-145-71
Package NDCs from labels
55111-145-71, 55111-145-12
Manufacturer
Sportpharm LLC
Effective date
2026-04-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluconazole - Sportpharm LLCSportpharm LLC2026-04-24HUMAN PRESCRIPTION DRUG LABEL
Fluconazole Tablets USPDr. Reddy's Laboratories Limited | Dr. Reddy's Laboratories Limited (FTO III)2025-09-23HUMAN PRESCRIPTION DRUG LABEL
FLUCONAZOLE - direct rxdirect rx2025-01-17HUMAN PRESCRIPTION DRUG LABEL
Fluconazole - Quality Care Products, LLCQuality Care Products, LLC2024-12-18HUMAN PRESCRIPTION DRUG LABEL
Fluconazole - Bryant Ranch PrepackBryant Ranch Prepack2024-10-07HUMAN PRESCRIPTION DRUG LABEL
Fluconazole - Redpharm DrugRedpharm Drug2024-08-09HUMAN PRESCRIPTION DRUG LABEL
Fluconazole Tablets USPREMEDYREPACK INC.2024-04-02HUMAN PRESCRIPTION DRUG LABEL
Fluconazole Tablets USPNucare Pharmaceuticals,Inc | NuCare Pharmaceuticals,Inc.2017-07-20HUMAN PRESCRIPTION DRUG LABEL

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 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 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 13 · 253 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluconazoleFLUCONAZOLEREMEDYREPACK INC.aaf9e5f8-048e-407c-bc11-ad4edff85c052026-09-10Warnings, Adverse reactionsExact identifier
rxcui: 197698
unii: 8VZV102JFY
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
FluconazoleFLUCONAZOLEREMEDYREPACK INC.1c82929f-934b-4df4-b24f-1e5da090fd8a2026-09-04Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
FluconazoleFLUCONAZOLEREMEDYREPACK INC.2bd1c038-ab82-496c-8129-3182238ad1a12026-09-01Warnings, Adverse reactionsExact identifier
rxcui: 197698
unii: 8VZV102JFY
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
fluconazoleFLUCONAZOLEPreferred Pharmaceuticals Inc.16b6fba0-b96f-4252-a70d-31dc614002982026-08-20Warnings, Adverse reactionsExact identifier
application number: ANDA208963
rxcui: 197700
unii: 8VZV102JFY
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
FluconazoleFLUCONAZOLEREMEDYREPACK INC.485f0414-036f-4f42-87ee-a89543ac94c12026-08-10Warnings, Adverse reactionsExact identifier
rxcui: 197701
unii: 8VZV102JFY
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
fluconazoleFLUCONAZOLEA-S Medication Solutions7961c029-746c-48c3-888b-8f83441028732026-07-30Warnings, Adverse reactionsExact identifier
application number: ANDA208963
rxcui: 197700
unii: 8VZV102JFY
FluconazoleFLUCONAZOLESt. Mary's Medical Park Pharmacyc89c3bbd-1170-4170-e053-2a95a90a8e412026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.