FDA.reportPublic FDA data

NDC 51079-608-01 - Fenofibrate

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
51079-608
Requested NDC
51079-608-01
Package NDCs from labels
51079-608-01, 51079-608-20
Manufacturer
Mylan Institutional Inc.
Effective date
2025-07-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fenofibrate - Mylan Institutional Inc.Mylan Institutional Inc.2025-07-25HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51079-608-01Fenofibrate1 in 1 BLISTER PACKTABLET, FILM COATED112
51079-608-20Fenofibrate100 in 1 CARTONTABLET, FILM COATED10012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-608FENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]11Current NDC, Legacy NDC, 2 package rows20220717_5a90e0a4-7892-462f-9776-037d23a93b10.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-608-01EA - Each51079-6086aa31359-a02a-4934-9490-3a650b17c2e812013-07-02
51079-608-20EA - Each51079-608cb3e9ba2-3c4d-45a5-a615-9142296ec8a712013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENOFIBRATEACTIVE INGREDIENTU202363UOSFENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
FENOFIBRATEACTIVE MOIETYU202363UOSFENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62FENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990FENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554FENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UFENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEFENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2

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 1 of 115 · 2,291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: 532B59J990
FenofibrateFENOFIBRATEA-S Medication Solutionsc870ea48-5dde-4a6f-9ddb-56b494bb2b552026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 477560
unii: U202363UOS
FENOFIBRATEFENOFIBRATEREMEDYREPACK INC.882ee82a-3c56-4173-af42-68c3aadc8aa72026-09-04Warnings, Adverse reactionsExact identifier
unii: U202363UOS
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: 532B59J990
FenofibrateFENOFIBRATEA-S Medication Solutionsd0c7070e-b3bb-4b5b-8a62-4e3136b5accc2026-08-28Warnings, Adverse reactionsExact identifier
rxcui: 477562
unii: U202363UOS
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: C151H8M554

Reported adverse events (FAERS/openFDA)#

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