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 5 of 6 · 118 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FLUCONAZOLEFLUCONAZOLEdirect rxb3db505a-9677-6f5a-e053-2a95a90a13d42025-01-17Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197699
unii: 8VZV102JFY
FluconazoleFLUCONAZOLENuCare Pharmaceuticals,Inc.068623f9-0f87-50bc-e063-6294a90aea002025-01-14Warnings, Adverse reactionsExact identifier
application number: ANDA077731
rxcui: 197699
unii: 8VZV102JFY
FluconazoleFLUCONAZOLENuCare Pharmaceuticals, Inc.2b9b08b6-7239-473b-e063-6294a90ab7c42025-01-13Warnings, Adverse reactionsExact identifier
application number: ANDA077731
rxcui: 197698
unii: 8VZV102JFY
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
application number: ANDA077731
rxcui: 197699
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEAurobindo Pharma Limited6ebf24fd-41cd-4b3c-8176-a1436253ba2d2024-11-14Warnings, Adverse reactionsExact identifier
application number: ANDA077731
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEProficient Rx LP4eaf5b04-c026-4a49-879f-2925b375f9032024-11-01Warnings, Adverse reactionsExact identifier
application number: ANDA077731
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
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
rxcui: 197699
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEBryant Ranch Prepack3f743514-615e-4e78-8321-24c545a7752f2024-09-06Warnings, Adverse reactionsExact identifier
application number: ANDA077731
rxcui: 197700
unii: 8VZV102JFY
FluconazoleFLUCONAZOLERising Pharma Holdings, Inc.ccbe0991-27a1-4ddb-bfc7-1b3422e533902024-08-22Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY
FluconazoleFLUCONAZOLENorthStar Rx LLCafde17e7-b95b-4cd5-97eb-e361724014bd2024-08-22Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEAurobindo Pharma Limitedbf588f7e-89de-4b4e-8d33-c1ff2be1b34e2024-08-09Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY
FluconazoleFLUCONAZOLENorthStar Rx LLCd2acccda-8068-46c1-8562-950d7f70ee062024-07-04Warnings, Adverse reactionsExact identifier
application number: ANDA077731
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
unii: 8VZV102JFY
FluconazoleFLUCONAZOLERising Pharma Holdings, Inc.2ca7efcd-4a8d-4139-a3eb-930afd18b13f2024-07-04Warnings, Adverse reactionsExact identifier
application number: ANDA077731
ndc (product): 57237-005
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
spl id: 1018b9ad-7145-49b4-903a-b483797d7c86
spl set id: 2ca7efcd-4a8d-4139-a3eb-930afd18b13f
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEHikma Pharmaceuticals USA Inc.d3ca59bd-ae00-48ab-89aa-87c7f56e99892024-06-28Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY

Reported adverse events (FAERS/openFDA)#

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