FDA.reportPublic FDA data

NDC 68084-735-11 - 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
68084-735
Requested NDC
68084-735-11
Package NDCs from labels
68084-735-11, 68084-735-01
Manufacturer
American Health Packaging
Effective date
2025-07-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluconazole - American Health PackagingAmerican Health Packaging2025-07-23HUMAN PRESCRIPTION DRUG LABEL
Fluconazole - Cardinal HealthCardinal Health2020-07-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-735-01Fluconazole100 in 1 BOX, UNIT-DOSETABLET10012
68084-735-11Fluconazole1 in 1 BLISTER PACKTABLET112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-735FLUCONAZOLE TABLET [AMERICAN HEALTH PACKAGING]10Current NDC, Legacy NDC, 2 package rows20240816_d7aacee3-9d9c-4b36-b735-39bcb9edf941.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-735-01EA - Each68084-735657e3eb7-d9f2-42c4-8dc6-325161bef75912014-10-03
68084-735-11EA - Each68084-7357460fb53-704c-4063-87b5-8f2278b765e512014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE TABLET [AMERICAN HEALTH PACKAGING]3
FLUCONAZOLEACTIVE MOIETY8VZV102JFYFLUCONAZOLE TABLET [AMERICAN HEALTH PACKAGING]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JFLUCONAZOLE TABLET [AMERICAN HEALTH PACKAGING]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUCONAZOLE TABLET [AMERICAN HEALTH PACKAGING]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUCONAZOLE TABLET [AMERICAN HEALTH PACKAGING]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUCONAZOLE TABLET [AMERICAN HEALTH PACKAGING]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUCONAZOLE TABLET [AMERICAN HEALTH PACKAGING]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EFLUCONAZOLE TABLET [AMERICAN HEALTH PACKAGING]3

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 10 · 182 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
FluconazoleFLUCONAZOLEREMEDYREPACK INC.1c82929f-934b-4df4-b24f-1e5da090fd8a2026-09-04Warnings, Adverse reactionsExact identifier
application number: ANDA077731
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
application number: ANDA077731
rxcui: 197698
unii: 8VZV102JFY
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
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
application number: ANDA077731
rxcui: 197701
unii: 8VZV102JFY
fluconazoleFLUCONAZOLEA-S Medication Solutions7961c029-746c-48c3-888b-8f83441028732026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 197700
unii: 8VZV102JFY
FluconazoleFLUCONAZOLESt. Mary's Medical Park Pharmacyc89c3bbd-1170-4170-e053-2a95a90a8e412026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
FluconazoleFLUCONAZOLERedpharm Drug568d9f2f-3394-b972-e063-6394a90a86282026-07-14Warnings, Adverse reactionsExact identifier
application number: ANDA077731
rxcui: 197699
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEPD-Rx Pharmaceuticals, Inc.6bb386b0-9dbe-40ee-b873-5215b19059202026-07-14Warnings, Adverse reactionsExact identifier
application number: ANDA077731
rxcui: 197699
unii: 8VZV102JFY
FLUCONAZOLEFLUCONAZOLEHAWAII REPACK, INC.8aa296e2-ad8d-42f6-8b41-468e2b9cdfb82026-07-03Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
FluconazoleFLUCONAZOLESt. Mary's Medical Park Pharmacy126406ae-1fdc-df20-e063-6294a90a27182026-06-29Warnings, Adverse reactionsExact identifier
application number: ANDA077731
rxcui: 197699
unii: 8VZV102JFY
fluconazoleFLUCONAZOLEBryant Ranch Prepack67af604c-928f-468b-ba27-ad45e95d3e7e2026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 197698
unii: 8VZV102JFY
fluconazoleFLUCONAZOLEBryant Ranch Prepack7259671f-a703-4a2a-81db-9a4839b340722026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 197700
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEA-S Medication Solutionsa995790a-8470-4c51-801a-69347151a6fe2026-06-24Warnings, Adverse reactionsExact identifier
application number: ANDA077731
rxcui: 197698
unii: 8VZV102JFY

Reported adverse events (FAERS/openFDA)#

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