FDA.reportPublic FDA data

NDC 68071-3474-01 - 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
68071-3474
Requested NDC
68071-3474-01
Package NDCs from labels
68071-3474-1, 68071-3474-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2025-11-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluconazole Tablets USP Rx onlyNuCare Pharmaceuticals,Inc.2025-11-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3474-1Fluconazole1 in 1 BLISTER PACKTABLET13
68071-3474-1Fluconazole12 in 1 CARTONTABLET123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3474FLUCONAZOLE TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 2 package rows20241115_01df20c4-7b94-044e-e063-6394a90a406a.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 4 of 6 · 118 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluconazoleFLUCONAZOLERadha Pharmaceuticals Inc4616c7ad-be61-7ac0-e063-6394a90ab9ed2025-12-10Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEA-S Medication Solutionsc6be26bb-af92-405b-9908-972d6e985cf02025-12-01Warnings, Adverse reactionsExact identifier
application number: ANDA077731
rxcui: 197700
unii: 8VZV102JFY
FluconazoleFLUCONAZOLENuCare Pharmaceuticals,Inc.01df20c4-7b94-044e-e063-6394a90a406a2025-11-17Warnings, Adverse reactionsExact identifier
application number: ANDA077731
ndc (package): 68071-3474-1
ndc (product): 68071-3474
ndc11 (package): 68071347401
rxcui: 197699
spl id: 43cd3f95-0325-4286-e063-6294a90a0572
spl set id: 01df20c4-7b94-044e-e063-6394a90a406a
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEPD-Rx Pharmaceuticals, Inc.28d53f27-a0cd-4d8d-e054-00144ff8d46c2025-10-15Warnings, Adverse reactionsExact identifier
application number: ANDA077731
rxcui: 197698
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEBryant Ranch Prepack701cd91f-4f79-48a7-8fe5-a9678d7a4ac82025-10-06Warnings, Adverse reactionsExact identifier
rxcui: 197698
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEDr. Reddy's Laboratories Limitedd7fa1d79-4cd3-4a55-b74b-b31e82e616a32025-09-23Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEProficient Rx LPfef2222c-5d61-435e-8761-d8f3d435d6d82025-09-01Warnings, Adverse reactionsExact identifier
application number: ANDA077731
rxcui: 197700
unii: 8VZV102JFY
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
application number: ANDA077731
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
FluconazoleFLUCONAZOLEBryant Ranch Prepack90538767-c84b-4637-8ab6-8c147315eafa2025-06-10Warnings, Adverse reactionsExact identifier
application number: ANDA077731
rxcui: 197699
unii: 8VZV102JFY
FluconazoleFLUCONAZOLECoupler LLC325d5d69-5132-79ea-e063-6294a90afdd02025-04-09Warnings, Adverse reactionsExact identifier
rxcui: 197701
unii: 8VZV102JFY
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
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
application number: ANDA077731
rxcui: 197700
unii: 8VZV102JFY
FluconazoleFLUCONAZOLENuCare Pharmaceuticals,Inc.0aacafca-baf8-9a22-e063-6394a90a2ca92025-02-03Warnings, Adverse reactionsExact identifier
application number: ANDA077731
rxcui: 197700
unii: 8VZV102JFY
FLUCONAZOLEFLUCONAZOLEDirect Rxdb886cfe-ea23-50c9-e053-2995a90a4d102025-01-22Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEDirect_Rx06f8f4b9-5289-2d59-e063-6294a90a72092025-01-22Warnings, Adverse reactionsExact identifier
application number: ANDA077731
rxcui: 197700
unii: 8VZV102JFY
FluconazoleFLUCONAZOLESlate Run Pharmaceuticals13804efd-7cb3-431f-a6a7-bd6d1da5889e2025-01-21Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY

Reported adverse events (FAERS/openFDA)#

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