FDA.reportPublic FDA data

NDC 70710-1139-01 - 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
70710-1139
Requested NDC
70710-1139-01
Package NDCs from labels
70710-1139-3, 70710-1139-1, 70710-1139-5, 70710-1139-7, 70710-1139-8, 70710-1139-01
Manufacturer
Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Limited
Effective date
2026-04-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
fluconazole - Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences LimitedZydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Limited2026-04-07HUMAN PRESCRIPTION DRUG LABEL
fluconazole - A-S Medication SolutionsA-S Medication Solutions2026-01-13HUMAN PRESCRIPTION DRUG LABEL
FLUCONAZOLE - direct rxdirect rx2025-01-17HUMAN PRESCRIPTION DRUG LABEL
fluconazole - St. Mary's Medical Park PharmacySt. Mary's Medical Park Pharmacy2024-12-12HUMAN PRESCRIPTION DRUG LABEL
Fluconazole Tablets, USP Rx onlyREMEDYREPACK INC.2023-03-16HUMAN PRESCRIPTION DRUG LABEL
Fluconazole Tablets, USP Rx onlyPreferred Pharmaceuticals Inc.2022-05-19HUMAN PRESCRIPTION DRUG LABEL
fluconazole - Bryant Ranch PrepackBryant Ranch Prepack2022-05-02HUMAN PRESCRIPTION DRUG LABEL
Fluconazole Tablets, USP Rx onlyNuCare Pharmaceuticals,Inc.2021-02-01HUMAN PRESCRIPTION DRUG LABEL
fluconazole - A-S Medication SolutionsA-S Medication Solutions2020-07-09HUMAN PRESCRIPTION DRUG LABEL
fluconazole - Proficient Rx LPProficient Rx LP2019-10-01HUMAN PRESCRIPTION DRUG LABEL
Fluconazole Tablets, USP Rx onlyPreferred Pharmaceuticals Inc.2019-09-20HUMAN PRESCRIPTION DRUG LABEL
Fluconazole Tablets, USP Rx onlyNuCare Pharmaceuticals,Inc.2018-05-17HUMAN PRESCRIPTION DRUG LABEL
fluconazole - Unit Dose ServicesUnit Dose Services2018-05-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1139-1fluconazole100 in 1 BOTTLETABLET10013
70710-1139-3fluconazole30 in 1 BOTTLETABLET3013
70710-1139-5fluconazole500 in 1 BOTTLETABLET50013
70710-1139-7fluconazole1 in 1 CARTONTABLET113
70710-1139-7fluconazole1 in 1 BLISTER PACKTABLET113
70710-1139-8fluconazole12 in 1 CARTONTABLET1213
70710-1139-8fluconazole1 in 1 BLISTER PACKTABLET113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1139FLUCONAZOLE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]12Current NDC, Legacy NDC, 7 package rows20240306_d1364455-1537-46d4-b093-38cca3be778f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1139-7EA - Each70710-1139f322c59a-6f95-4228-834d-25a884d0c88b12019-03-12
70710-1139-8EA - Each70710-1139a8cd2cd6-a746-4ed1-b086-441725c3035212018-02-20

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 · 258 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.