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 9 of 13 · 246 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PowderTITANIUM DIOXIDEOxygen Development LLC08b8003f-40be-3380-e063-6294a90a4f6b2025-09-05WarningsExact identifier
unii: 1K09F3G675
FluconazoleFLUCONAZOLEProficient Rx LPfef2222c-5d61-435e-8761-d8f3d435d6d82025-09-01Warnings, Adverse reactionsExact identifier
rxcui: 197700
unii: 8VZV102JFY
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYFSA Store Inc.3cd18f96-34f7-3f2c-e063-6294a90a3b7e2025-08-19WarningsExact identifier
unii: 1K09F3G675
FluconazoleFLUCONAZOLEANI Pharmaceuticals, Inc.8f90f169-6a72-4c33-a2af-0bc943602bc22025-08-08Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEAmerican Health Packagingd7aacee3-9d9c-4b36-b735-39bcb9edf9412025-07-23Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197700
unii: 8VZV102JFY
Schuessler Tissue Salts Calc Phos Bone Health 2CALCAREA PHOSPHORICAMartin & Pleasance Pty Ltdc277f1d8-2ee0-4111-adb6-38998f77dede2025-07-18WarningsExact identifier
unii: L11K75P92J
Schuessler Tissue Salts Calc Phos Bone Health 2CALCAREA PHOSPHORICAMartin & Pleasance Pty Ltd81d59754-1b36-4f71-aec1-5335b003a96f2025-07-01WarningsExact identifier
unii: L11K75P92J
Ferrum rosatum GraphitesFERRUM ROSATUM GRAPHITESUriel Pharmacy Inc.1a4ca338-eada-4c0f-8bce-480244940c892025-06-27WarningsExact identifier
unii: 1K09F3G675
FluconazoleFLUCONAZOLEBryant Ranch Prepack90538767-c84b-4637-8ab6-8c147315eafa2025-06-10Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
AquavitAQUAVITUriel Pharmacy Inc.c1c0887a-c388-c737-e053-2a95a90a076c2025-06-06WarningsExact identifier
unii: 1K09F3G675
PowderTITANIUM DIOXIDEOxygen Development LLC08b7eeeb-09ae-ffe6-e063-6294a90aba902025-05-07WarningsExact identifier
unii: 1K09F3G675
FluconazoleFLUCONAZOLECoupler LLC325d5d69-5132-79ea-e063-6294a90afdd02025-04-09Warnings, Adverse reactionsExact identifier
rxcui: 197701
unii: 8VZV102JFY
RID Poison Ivy Rash ReliefCALAMINE AND ZINC OXIDEOystershell Consumer Health Inc.36c3af9a-2646-4427-e063-6394a90a2c5e2025-03-13WarningsExact identifier
unii: 1K09F3G675
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
unii: FZ989GH94E
CalamineFERRIC OXIDE REDPreferred Pharmaceuticals Inc.326f3d80-c1bf-4cf0-a662-58e02ed7ee672025-02-12Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
FluconazoleFLUCONAZOLENuCare Pharmaceuticals,Inc.cf6c7cca-d074-2178-e053-2a95a90a3af72025-02-10Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
FluconazoleFLUCONAZOLENuCare Pharmaceuticals,Inc.fd7ea788-29b7-1f0b-e053-6394a90a29802025-02-04Warnings, Adverse reactionsExact identifier
rxcui: 197700
unii: 8VZV102JFY
FluconazoleFLUCONAZOLENuCare Pharmaceuticals,Inc.0aacafca-baf8-9a22-e063-6394a90a2ca92025-02-03Warnings, Adverse reactionsExact identifier
rxcui: 197700
unii: 8VZV102JFY
FLUCONAZOLEFLUCONAZOLEDirect Rxdb886cfe-ea23-50c9-e053-2995a90a4d102025-01-22Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY

Reported adverse events (FAERS/openFDA)#

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