FDA.reportPublic FDA data

NDC 68001-253-21 - 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
68001-253
Requested NDC
68001-253-21
Package NDCs from labels
68001-253-21, 68001-253-20, 68001-253-44, 68001-253-17
Manufacturer
BluePoint Laboratories | Glenmark Pharmaceuticals Inc | Glenmark Generics Limited
Effective date
2025-12-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluconazole TabletsBluePoint Laboratories | Glenmark Pharmaceuticals Inc | Glenmark Generics Limited2025-12-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-253-17Fluconazole12 in 1 CARTONTABLET1220
68001-253-20Fluconazole12 in 1 CARTONTABLET1220
68001-253-21Fluconazole1 in 1 BLISTER PACKTABLET120
68001-253-44Fluconazole1 in 1 BLISTER PACKTABLET120

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-253FLUCONAZOLE TABLET [BLUEPOINT LABORATORIES]19Current NDC, Legacy NDC, 4 package rows20240621_83bcb8fc-53f1-4d7b-b083-0905b52c6c7e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-253-17EA - Each68001-253916c50fe-5eb4-4af1-864d-4815f169fa9c12021-12-08
68001-253-20EA - Each68001-253d10671d6-1dfd-4168-8dd4-5e65a14a5ba112014-05-02
68001-253-21EA - Each68001-253beac3d5b-853c-4f5f-979f-105f7ca5f72212014-05-02
68001-253-44EA - Each68001-253c6b63a82-ee57-4b42-b089-de1328233b9712021-12-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE TABLET [BLUEPOINT LABORATORIES]5
FLUCONAZOLEACTIVE MOIETY8VZV102JFYFLUCONAZOLE TABLET [BLUEPOINT LABORATORIES]5
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JFLUCONAZOLE TABLET [BLUEPOINT LABORATORIES]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUCONAZOLE TABLET [BLUEPOINT LABORATORIES]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUCONAZOLE TABLET [BLUEPOINT LABORATORIES]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUCONAZOLE TABLET [BLUEPOINT LABORATORIES]5
POVIDONESINACTIVE INGREDIENTFZ989GH94EFLUCONAZOLE TABLET [BLUEPOINT LABORATORIES]5

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 9 · 180 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluconazoleFLUCONAZOLEREMEDYREPACK INC.aaf9e5f8-048e-407c-bc11-ad4edff85c052026-09-10Warnings, Adverse reactionsExact identifier
application number: ANDA077253
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
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
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
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
application number: ANDA077253
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
rxcui: 197699
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEPD-Rx Pharmaceuticals, Inc.6bb386b0-9dbe-40ee-b873-5215b19059202026-07-14Warnings, Adverse reactionsExact identifier
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
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
rxcui: 197698
unii: 8VZV102JFY

Reported adverse events (FAERS/openFDA)#

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