FDA.reportPublic FDA data

NDC 67046-2000-03 - 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
67046-2000
Requested NDC
67046-2000-03
Package NDCs from labels
67046-2000-3, 67046-2000-03
Manufacturer
Coupler LLC | Glenmark Pharmaceuticals Inc
Effective date
2026-05-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluconazole - Coupler LLC | Glenmark Pharmaceuticals IncCoupler LLC | Glenmark Pharmaceuticals Inc2026-05-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-2000-3Fluconazole30 in 1 BLISTER PACKTABLET301

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 8 of 9 · 177 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
rxcui: 197698
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEPharmasource Meds, LLCfe0cc56d-c0b6-f859-e053-6294a90ad9322024-05-28Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
Clear Eyes Natural TearsPOLYVINYL ALCOHOL AND POVIDONEPrestige Brands Holdings, Inc.efba3eb0-798d-4635-b19b-4970e45b3cc92024-04-01WarningsExact identifier
unii: FZ989GH94E
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
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
FluconazoleFLUCONAZOLEDirect Rx69f199fa-bb92-4837-8b12-427a1c71f6222024-01-09Adverse reactionsExact identifier
rxcui: 197700
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

Reported adverse events (FAERS/openFDA)#

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