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 11 of 13 · 248 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluconazoleFLUCONAZOLEBryant Ranch Prepack3f743514-615e-4e78-8321-24c545a7752f2024-09-06Warnings, Adverse reactionsExact identifier
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
1fc0bf3f-5a90-a287-e063-6394a90a4c4f1fc0d542-ec85-85fb-e063-6294a90a17022024-08-15Warnings, Adverse reactionsExact identifier
spl id: 1fc0bf3f-5a90-a287-e063-6394a90a4c4f
spl set id: 1fc0d542-ec85-85fb-e063-6294a90a1702
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
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
unii: 8VZV102JFY
FluconazoleFLUCONAZOLERising Pharma Holdings, Inc.2ca7efcd-4a8d-4139-a3eb-930afd18b13f2024-07-04Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEHikma Pharmaceuticals USA Inc.d3ca59bd-ae00-48ab-89aa-87c7f56e99892024-06-28Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEBaxter Healthcare Companycd24a261-9c15-42b4-8040-89d2dbda174e2024-06-24Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY
Artificial TearsPOLYVINYL ALCOHOL, POVIDONENuCare Pharmaceuticals,Inc.9c1c4911-908e-3c3c-e053-2995a90abcfc2024-06-14WarningsExact identifier
unii: FZ989GH94E
fluconazoleFLUCONAZOLENuCare Pharmaceuticals,Inc.715c53f0-2aea-1f24-e053-2995a90ad4632024-06-10Warnings, Adverse reactionsExact identifier
application number: ANDA208963
rxcui: 197698
unii: 8VZV102JFY
CalamineFERRIC OXIDE REDNuCare Pharmaceuticals,Inc.66e98554-e158-a519-e053-2a91aa0a67832024-06-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
FluconazoleFLUCONAZOLEPharmasource Meds, LLCfe0cc56d-c0b6-f859-e053-6294a90ad9322024-05-28Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
efc0e7f8-e803-456a-95e4-42a1a76026ab512001ae-2fa8-406b-a5a7-152d4d3c6d752024-04-24Warnings, Adverse reactionsExact identifier
spl set id: 512001ae-2fa8-406b-a5a7-152d4d3c6d75
Clear Eyes Natural TearsPOLYVINYL ALCOHOL AND POVIDONEPrestige Brands Holdings, Inc.efba3eb0-798d-4635-b19b-4970e45b3cc92024-04-01WarningsExact identifier
unii: FZ989GH94E
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
REFRESH CLASSICPOLYVINYL ALCOHOL, POVIDONEA-S Medication Solutions3bf6193c-56db-45ad-844c-58eb8c33cba92024-03-14WarningsExact identifier
unii: FZ989GH94E
fluconazoleFLUCONAZOLEZydus Lifesciences Limited0adb2f88-8a6f-4f33-9e2d-73f537e053132024-03-04Warnings, Adverse reactionsExact identifier
application number: ANDA208963
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
unii: 8VZV102JFY
GOODSENSE ARTIFICIAL TEARSPOLYVINYL ALCOHOLProficient Rx LPf29c792c-6cb2-449f-b97d-6304a58dec2a2024-02-01WarningsExact identifier
unii: FZ989GH94E
GoodSense Artifical TearsPOLYVINYL ALCOHOL, AND POVIDONEProficient Rx LPcd24da78-fd90-4a9c-8e5f-f7fc56ec0fc92024-02-01WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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