FDA.reportPublic FDA data

NDC 70710-1138-01 - 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
70710-1138
Requested NDC
70710-1138-01
Package NDCs from labels
70710-1138-3, 70710-1138-1, 70710-1138-5, 70710-1138-4, 70710-1138-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluconazole Tablets, USP Rx onlyREMEDYREPACK INC.2026-09-21HUMAN PRESCRIPTION DRUG LABEL
fluconazole - Bryant Ranch PrepackBryant Ranch Prepack2026-06-24HUMAN PRESCRIPTION DRUG LABEL
fluconazole - Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences LimitedZydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Limited2026-04-07HUMAN PRESCRIPTION DRUG LABEL
FLUCONAZOLE - direct rxdirect rx2025-01-17HUMAN PRESCRIPTION DRUG LABEL
Fluconazole Tablets, USP Rx onlyNuCare Pharmaceuticals,Inc.2024-06-10HUMAN PRESCRIPTION DRUG LABEL
Fluconazole Tablets, USP Rx onlyNuCare Pharmaceuticals,Inc.2023-07-14HUMAN PRESCRIPTION DRUG LABEL
fluconazole - A-S Medication SolutionsA-S Medication Solutions2023-02-06HUMAN PRESCRIPTION DRUG LABEL
fluconazole - Denton Pharma, Inc. DBA Northwind PharmaceuticalsDenton Pharma, Inc. DBA Northwind Pharmaceuticals2021-12-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1138-1fluconazole100 in 1 BOTTLETABLET10013
70710-1138-3fluconazole30 in 1 BOTTLETABLET3013
70710-1138-4fluconazole10 in 1 CARTONTABLET1013
70710-1138-4fluconazole10 in 1 BLISTER PACKTABLET1013
70710-1138-5fluconazole500 in 1 BOTTLETABLET50013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1138FLUCONAZOLE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]12Current NDC, Legacy NDC, 5 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
70710-1138-1EA - Each70710-113838c9875f-341e-4ada-9a4d-b52be786da3712018-02-20
70710-1138-3EA - Each70710-1138e4a2ebad-6a59-4a30-a7a6-ec3db19c6e0b12018-02-20

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 13 of 13 · 246 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluconazoleFLUCONAZOLEAsclemed USA, Inc.56a9de97-bbb9-4210-9ace-f77317d5f33b2022-03-04Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
d3a8edf1-8a26-3355-e053-2995a90ae452d3a8f0e4-cf55-2df6-e053-2a95a90a221c2021-12-21Warnings, Adverse reactionsExact identifier
spl id: d3a8edf1-8a26-3355-e053-2995a90ae452
spl set id: d3a8f0e4-cf55-2df6-e053-2a95a90a221c
Melange combinationCALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEASeroyal USA0a071fbf-0075-4479-e054-00144ff8d46c2021-07-14WarningsExact identifier
unii: L11K75P92J
MEDULLOSSEINUM PLEXARNICA MONTANA, CALCAREA PHOSPHORICA, CALENDULA OFFICINALIS, HYPERICUM PERFORATUM, MEDULLOSSEINUM, PULSATILLA, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALESeroyal USA22b7eafe-ef76-0677-e054-00144ff88e882020-10-09WarningsExact identifier
unii: L11K75P92J
fluconazoleFLUCONAZOLEProficient Rx LPf232600e-70ce-4001-b9da-31442f0920b92020-03-01Warnings, Adverse reactionsExact identifier
application number: ANDA208963
rxcui: 197700
unii: 8VZV102JFY
fluconazoleFLUCONAZOLEProficient Rx LP7c8bb5ff-37e7-4f5e-8ea7-12269b2c7fd32019-10-01Warnings, Adverse reactionsExact identifier
application number: ANDA208963
rxcui: 197699
unii: 8VZV102JFY

Reported adverse events (FAERS/openFDA)#

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