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 2 of 6 · 118 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluconazoleFLUCONAZOLECoupler LLC519e44f4-9318-572e-e063-6394a90afe932026-05-12Warnings, Adverse reactionsExact identifier
rxcui: 197698
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEREMEDYREPACK INC.2cbf3c6c-318c-4dd9-ad44-a8eb9eccb0f52026-05-01Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
FluconazoleFLUCONAZOLECardinal Health 107, LLCf1bfba3a-5b18-41c0-9084-b1f26bb93ef22026-04-27Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197700
unii: 8VZV102JFY
FluconazoleFLUCONAZOLESportpharm LLC8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2026-04-24Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEPreferred Pharmaceuticals Inc.eeeb82e1-d668-418e-9716-f8bcf72f80c02026-04-17Warnings, Adverse reactionsExact identifier
application number: ANDA077731
rxcui: 197700
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEPreferred Pharmaceuticals Inc.5cbd78cd-2cd7-4882-9902-bdb7812fbc6b2026-04-16Warnings, Adverse reactionsExact identifier
application number: ANDA077731
rxcui: 197699
unii: 8VZV102JFY
fluconazoleFLUCONAZOLEZydus Pharmaceuticals (USA) Inc.d1364455-1537-46d4-b093-38cca3be778f2026-04-07Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEMylan Pharmaceuticals Inc.737e0fac-a2d2-4053-a0d7-edbfb6248f692026-04-02Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
unii: 8VZV102JFY
DiflucanFLUCONAZOLERoerigf694c617-3383-416c-91b6-b94fda3712042026-04-02Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEMajor Pharmaceuticals13184b13-e252-4b4d-a3e2-cfc4ad3d55b72026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197700
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEA-S Medication Solutionsf25f31a6-4bad-40fa-bced-695552e27afd2026-02-17Warnings, Adverse reactionsExact identifier
application number: ANDA077731
ndc (package): 50090-6842-2
ndc (package): 50090-6842-3
ndc (package): 50090-6842-1
ndc (package): 50090-6842-0
ndc (product): 50090-6842
rxcui: 197699
spl id: 8bc8e604-0cda-47c0-a195-6818eb6d9642
spl set id: f25f31a6-4bad-40fa-bced-695552e27afd
unii: 8VZV102JFY
FluconazoleFLUCONAZOLESportpharm LLC60f3e8af-d98f-48dd-83e6-a78315aaed222026-02-15Warnings, Adverse reactionsExact identifier
application number: ANDA077731
ndc (package): 85766-167-12
ndc (product): 85766-167
rxcui: 197699
spl id: 4ad6e03a-2618-5146-e063-6294a90ab3d0
spl set id: 60f3e8af-d98f-48dd-83e6-a78315aaed22
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEGolden State Medical Supply, Inc.c2c7242d-d172-4733-e053-2995a90acb2e2026-02-10Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEGlenmark Pharmaceuticals Inc., USA3da5f41d-5200-45ac-b89d-00881237ec852026-01-29Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEBryant Ranch Prepack2c9abaee-461f-437d-adda-e96d7ae3dd012026-01-23Warnings, Adverse reactionsExact identifier
rxcui: 197701
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEA-S Medication Solutionsa0f1c111-e11e-4b7e-b990-8bc271cbc9402026-01-14Warnings, Adverse reactionsExact identifier
rxcui: 197698
unii: 8VZV102JFY
fluconazoleFLUCONAZOLEA-S Medication Solutions1a8bd42a-2bce-4b41-8678-67033e7707dd2026-01-13Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
Pyrogenium Combination 9239PYROGENIUM COMBINATIONProfessional Complementary Health Formulas8b869987-bfd2-4451-a2a8-ce3a92e201f22026-01-08WarningsExact identifier
unii: L11K75P92J
Pneumo Drops 5018PNEUMO DROPSProfessional Complementary Health Formulasea6d0286-db1c-48c0-83fd-c18fa8f8629f2026-01-08WarningsExact identifier
unii: L11K75P92J
Rib Cage Pain Drops 2056RIB CAGE PAIN DROPSProfessional Complementary Health Formulasf8051769-9714-4444-b736-04b95af64a9b2026-01-08WarningsExact identifier
unii: L11K75P92J

Reported adverse events (FAERS/openFDA)#

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