NDC 70518-3312-1 - 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
70518-3312
Requested NDC
70518-3312-1
Package NDCs from labels
70518-3312-1, 70518-3312-0
Manufacturer
REMEDYREPACK INC.
Effective date
2025-07-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluconazole TabletsREMEDYREPACK INC.2025-07-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3312FLUCONAZOLE TABLET [REMEDYREPACK INC.]4Legacy NDC20240426_d11e0926-cd15-49ba-b0ee-2b6d4e009dd8.zip

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 7 · 121 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
FluconazoleFLUCONAZOLEREMEDYREPACK INC.1c82929f-934b-4df4-b24f-1e5da090fd8a2026-09-04Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEREMEDYREPACK INC.2bd1c038-ab82-496c-8129-3182238ad1a12026-09-01Warnings, Adverse reactionsExact identifier
rxcui: 197698
unii: 8VZV102JFY
fluconazoleFLUCONAZOLEPreferred Pharmaceuticals Inc.16b6fba0-b96f-4252-a70d-31dc614002982026-08-20Warnings, Adverse reactionsExact identifier
rxcui: 197700
unii: 8VZV102JFY
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
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
FluconazoleFLUCONAZOLENorthwind Health Company, LLC0de7211d-b8ce-214d-e063-6294a90aec412026-06-22Warnings, Adverse reactionsExact identifier
application number: ANDA077253
rxcui: 197699
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEREMEDYREPACK INC.726daf35-4c03-464f-a814-cc0a715d60312026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 197700
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEPD-Rx Pharmaceuticals, Inc.dd975843-c3e4-44f4-bb0d-33b294c1f6fb2026-06-12Warnings, Adverse reactionsExact identifier
application number: ANDA077253
rxcui: 197700
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEREMEDYREPACK INC.91adb548-9875-47e9-8054-578ed8c7572e2026-06-10Warnings, Adverse reactionsExact identifier
rxcui: 197698
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEASCLEMED USA INC.2099c3a0-1911-4d4a-878a-36cf054bdd0b2026-05-20Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEBryant Ranch Prepacke222031d-58f6-46d6-99f8-320b9aacf2b22026-05-18Warnings, Adverse reactionsExact identifier
application number: ANDA077253
rxcui: 197699
unii: 8VZV102JFY

Reported adverse events (FAERS/openFDA)#

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