FDA.reportPublic FDA data

NDC 16714-692-10 - 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
16714-692
Requested NDC
16714-692-10
Package NDCs from labels
16714-692-10, 16714-692-11
Manufacturer
Redpharm Drug
Effective date
2026-07-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluconazole - Redpharm DrugRedpharm Drug2026-07-14HUMAN PRESCRIPTION DRUG LABEL
Fluconazole - A-S Medication SolutionsA-S Medication Solutions2026-02-17Human Prescription Drug Label
Fluconazole - Sportpharm LLCSportpharm LLC2026-02-15HUMAN PRESCRIPTION DRUG LABEL
Fluconazole - NorthStar Rx LLC | Aurobindo Pharma LimitedNorthStar Rx LLC | Aurobindo Pharma Limited2024-07-04Human Prescription Drug Label
Fluconazole - Proficient Rx LPProficient Rx LP2023-01-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-692-10Fluconazole1 in 1 BLISTER PACKTABLET119
16714-692-11Fluconazole12 in 1 CARTONTABLET1219

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-692FLUCONAZOLE TABLET [NORTHSTAR RX LLC]19Current NDC, Legacy NDC, 2 package rows20240809_d2acccda-8068-46c1-8562-950d7f70ee06.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-692-10EA - Each16714-6920d028215-60b4-4b60-ac60-c65a4f4573a912014-01-04
16714-692-11EA - Each16714-692c9c5b78c-9794-45e8-81ce-862ec82bdcfc12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE TABLET [NORTHSTAR RX LLC]5
FLUCONAZOLEACTIVE MOIETY8VZV102JFYFLUCONAZOLE TABLET [NORTHSTAR RX LLC]5
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JFLUCONAZOLE TABLET [NORTHSTAR RX LLC]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUCONAZOLE TABLET [NORTHSTAR RX LLC]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUCONAZOLE TABLET [NORTHSTAR RX LLC]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUCONAZOLE TABLET [NORTHSTAR RX LLC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUCONAZOLE TABLET [NORTHSTAR RX LLC]5
POVIDONE K30INACTIVE INGREDIENTU725QWY32XFLUCONAZOLE TABLET [NORTHSTAR RX LLC]5

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
rxcui: 197699
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.