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 10 of 13 · 246 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluconazoleFLUCONAZOLEDirect_Rx06f8f4b9-5289-2d59-e063-6294a90a72092025-01-22Warnings, Adverse reactionsExact identifier
rxcui: 197700
unii: 8VZV102JFY
Prunus IronPRUNUS IRONUriel Pharmacy Inc.091be588-b62e-4919-8e9e-3edb9792d3192025-01-22WarningsExact identifier
unii: 1K09F3G675
FluconazoleFLUCONAZOLESlate Run Pharmaceuticals13804efd-7cb3-431f-a6a7-bd6d1da5889e2025-01-21Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY
FLUCONAZOLEFLUCONAZOLEdirect rxb3db505a-9677-6f5a-e053-2a95a90a13d42025-01-17Warnings, Adverse reactionsExact identifier
application number: ANDA208963
application number: ANDA076658
ndc (package): 72189-149-01
ndc (package): 72189-143-01
ndc (package): 72189-140-10
ndc (product): 72189-140
ndc (product): 72189-143
ndc (product): 72189-149
rxcui: 197698
rxcui: 197699
spl id: 2becff06-7cc2-1200-e063-6294a90ad1ec
spl set id: b3db505a-9677-6f5a-e053-2a95a90a13d4
unii: 8VZV102JFY
FluconazoleFLUCONAZOLENuCare Pharmaceuticals,Inc.068623f9-0f87-50bc-e063-6294a90aea002025-01-14Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
FluconazoleFLUCONAZOLENuCare Pharmaceuticals, Inc.2b9b08b6-7239-473b-e063-6294a90ab7c42025-01-13Warnings, Adverse reactionsExact identifier
rxcui: 197698
unii: 8VZV102JFY
Ferrum Silicicum UrticaFERRUM SILICICUM URTICAUriel Pharmacy Inc.09829ac4-c074-7315-e063-6394a90adf592025-01-07WarningsExact identifier
unii: 1K09F3G675
FluconazoleFLUCONAZOLEHospira, Inc22ebc3fb-ee81-44bd-a6e3-5e759ee724a82024-12-05Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEA-S Medication Solutions177322f4-9526-40cb-9e5d-bc24e8fb02db2024-11-18Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEAurobindo Pharma Limited6ebf24fd-41cd-4b3c-8176-a1436253ba2d2024-11-14Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEProficient Rx LP4eaf5b04-c026-4a49-879f-2925b375f9032024-11-01Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
FLUCONAZOLEFLUCONAZOLEChartwell RX, LLCf86ea347-78f5-43b8-9574-a52569a4237b2024-10-28Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
unii: 8VZV102JFY
Clear Eyes Triple ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.1269a1a6-843d-4d08-bb3c-c1f3d2e7080d2024-10-25WarningsExact identifier
unii: FZ989GH94E
CaladrylFERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDEBausch Health US, LLC67d4fd42-9fed-4238-9f5a-c9403abbcf202024-10-17WarningsExact identifier
unii: 1K09F3G675
FluconazoleFLUCONAZOLEBryant Ranch Prepackc94b8ecf-249f-42d6-a030-4cfb83fddb082024-10-08Warnings, Adverse reactionsExact identifier
rxcui: 197698
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEBryant Ranch Prepack877aea10-b019-4eeb-8a1e-e6ac583df9662024-10-08Warnings, Adverse reactionsExact identifier
rxcui: 197700
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEBryant Ranch Prepackb94ca865-ab2f-466c-9913-dde9376e45332024-10-08Warnings, Adverse reactionsExact identifier
rxcui: 197701
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEBryant Ranch Prepack6b2bc10f-21a8-422a-9ea3-ed7788ffce6b2024-10-07Warnings, Adverse reactionsExact identifier
rxcui: 197700
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEBryant Ranch Prepacka499c43e-0454-4a8c-a547-31e9816babdd2024-10-07Warnings, Adverse reactionsExact identifier
application number: ANDA076658
rxcui: 197699
unii: 8VZV102JFY
CalamineCALAMINE AND ZINC OXIDEStrategic Sourcing Services, LLC22173332-9d09-768c-e063-6394a90a94e12024-09-14WarningsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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