FDA.reportPublic FDA data

NDC 70710-1140-01 - 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
70710-1140
Requested NDC
70710-1140-01
Package NDCs from labels
70710-1140-3, 70710-1140-1, 70710-1140-5, 70710-1140-4, 70710-1140-01
Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-08-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluconazole Tablets, USP Rx onlyPreferred Pharmaceuticals Inc.2026-08-20HUMAN PRESCRIPTION DRUG LABEL
fluconazole - A-S Medication SolutionsA-S Medication Solutions2026-07-30HUMAN 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 Tablets, USP Rx onlyREMEDYREPACK INC.2024-09-11HUMAN PRESCRIPTION DRUG LABEL
fluconazole - RedPharm DrugRedPharm Drug2024-08-15HUMAN PRESCRIPTION DRUG LABEL
Fluconazole - Direct RxDirect Rx2024-01-09HUMAN PRESCRIPTION DRUG LABEL
Fluconazole Tablets, USP Rx onlyPreferred Pharmaceuticals Inc.2023-06-08HUMAN PRESCRIPTION DRUG LABEL
Fluconazole Tablets, USP Rx onlyNuCare Pharmaceuticals,Inc.2022-01-03HUMAN PRESCRIPTION DRUG LABEL
fluconazole - Proficient Rx LPProficient Rx LP2020-03-01HUMAN PRESCRIPTION DRUG LABEL
fluconazole - Bryant Ranch PrepackBryant Ranch Prepack2019-08-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1140-1fluconazole100 in 1 BOTTLETABLET10013
70710-1140-3fluconazole30 in 1 BOTTLETABLET3013
70710-1140-4fluconazole10 in 1 BLISTER PACKTABLET1013
70710-1140-4fluconazole10 in 1 CARTONTABLET1013
70710-1140-5fluconazole500 in 1 BOTTLETABLET50013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1140FLUCONAZOLE 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
70710-1140-1EA - Each70710-1140661b5f73-5fe3-425b-8a7f-c5c384fc210412018-02-20
70710-1140-3EA - Each70710-1140f43ad117-c887-4f28-851a-6e9aea4c970f12018-02-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYDIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
FLUCONAZOLEACTIVE MOIETY8VZV102JFYDIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JDIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
magnesium stearateINACTIVE INGREDIENT70097M6I30DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
povidoneINACTIVE INGREDIENTFZ989GH94EDIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]1

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 12 of 13 · 248 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluconazoleFLUCONAZOLEDirect Rx69f199fa-bb92-4837-8b12-427a1c71f6222024-01-09Adverse reactionsExact identifier
application number: ANDA208963
ndc (package): 61919-380-03
ndc (package): 61919-493-03
ndc (product): 61919-493
ndc (product): 61919-380
rxcui: 197700
spl id: 0e88c9e2-8dbd-917c-e063-6294a90a6ec9
spl set id: 69f199fa-bb92-4837-8b12-427a1c71f622
unii: 8VZV102JFY
Sunmark Eye Drops Advanced Moisturizer/LubricantDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINEStrategic Sourcing Services LLC0daa4e39-0447-44b6-a7d7-370b12bf94512023-12-23WarningsExact identifier
unii: FZ989GH94E
Meijer Artificial TearsPOLYVINYL ALCOHOL, POVIDONEMeijer Distribution, Inc.9feb3eec-a36f-8fc7-e053-2a95a90adcd32023-12-22WarningsExact identifier
unii: FZ989GH94E
Meijer Advanced Redness and Irritation ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCIMeijer Distribution, Inc.9fea6d7a-a2cd-d26e-e053-2995a90a15f82023-12-22WarningsExact identifier
unii: FZ989GH94E
Walgreens Eye Drops Advanced Relief 15mLDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCIWalgreen Company949f5560-fba7-2da8-e053-2995a90a23c22023-12-20WarningsExact identifier
unii: FZ989GH94E
Signature Care Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLBetter Living Brands LLC5d7228ce-f108-4cc2-9aec-8b4548c3a1552023-12-20WarningsExact identifier
unii: FZ989GH94E
Kroger Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEKroger Companyf7ad77fc-d890-25b9-e053-6394a90a2b122023-12-20WarningsExact identifier
unii: FZ989GH94E
Equaline Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEUnited Natural Foods, Inc.f7602789-179a-edfc-e053-6294a90a08442023-12-20WarningsExact identifier
unii: FZ989GH94E
Topcare Health Artificial TearsPOLYVINYL ALCOHOL, POVIDONETopco Associates LLC9c614c0e-5862-682f-e053-2a95a90abc092023-12-20WarningsExact identifier
unii: FZ989GH94E
TopCare Health Advanced Moisturizing Plus Redness ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLTopco Associates LLC9c6193a6-d822-1b27-e053-2995a90ab3cf2023-12-20WarningsExact identifier
unii: FZ989GH94E
HEB Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHEB Grocery Company, LPf76281d6-3aea-349b-e053-6394a90afca22023-12-20WarningsExact identifier
unii: FZ989GH94E
FluconazoleFLUCONAZOLEA-S Medication Solutions2fcac0e4-4f12-42d2-b129-106b4e1000752023-12-03Warnings, Adverse reactionsExact identifier
application number: ANDA077253
rxcui: 197699
unii: 8VZV102JFY
Good Neighbor Pharmacy Artifical Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEProficient Rx LP73e12596-6dd5-4cd2-83ed-992e1211b4b82023-12-01WarningsExact identifier
unii: FZ989GH94E
FluconazoleFLUCONAZOLEProficient Rx LPfc4fccd8-19d2-4704-afa9-9ce0ab1d2b5f2023-10-01Warnings, Adverse reactionsExact identifier
rxcui: 197700
unii: 8VZV102JFY
FLUCONAZOLEFLUCONAZOLEAsclemed USA, Inc.3208dc64-6117-4b2d-9008-76a819cef7d72023-09-01Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
Ferrum OxydatumFERRUM OXYDATUMHahnemann Laboratories, INC.f8b52d3f-3fe2-a850-e053-6394a90a5d9f2023-04-06Exact identifier
unii: 1K09F3G675
FluconazoleFLUCONAZOLEProficient Rx LPfa2fa2f8-f3a6-4bc0-943c-03dabd0f15812023-04-01Warnings, Adverse reactionsExact identifier
application number: ANDA077253
rxcui: 197699
unii: 8VZV102JFY
fluconazoleFLUCONAZOLEA-S Medication Solutions08a54805-4fdf-48fd-bc3e-e9fa38f3c6912023-02-06Warnings, Adverse reactionsExact identifier
application number: ANDA208963
rxcui: 197698
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEProficient Rx LPb0aa9b22-5aef-459f-bb11-b193343eeb862023-02-01Warnings, Adverse reactionsExact identifier
rxcui: 197698
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEProficient Rx LP88d9904c-0c21-4188-95e2-6479bdf359df2023-01-01Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY

Reported adverse events (FAERS/openFDA)#

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