FDA.reportPublic FDA data

NDC 50268-313-11 - 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
50268-313
Requested NDC
50268-313-11
Package NDCs from labels
50268-313-11, 50268-313-15
Manufacturer
AvPAK
Effective date
2025-11-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FENOFIBRATE - AvPAKAvPAK2025-11-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-313-11FENOFIBRATE1 in 1 BLISTER PACKTABLET16
50268-313-15FENOFIBRATE50 in 1 BOX, UNIT-DOSETABLET506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-313FENOFIBRATE TABLET [AVPAK]5Current NDC, Legacy NDC, 2 package rows20230321_d4e1d692-3c03-7406-ee06-7a6fb39ed3e7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-313-11EA - Each50268-31354b639b1-99a6-4912-98a5-886f4aba412412015-09-10
50268-313-15EA - Each50268-31302830ac9-1d8f-41bf-bacb-882872b8564712015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENOFIBRATEACTIVE INGREDIENTU202363UOSFENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
FENOFIBRATEACTIVE MOIETYU202363UOSFENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
D&c Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GFENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
Fd&c Yellow No. 6INACTIVE INGREDIENTH77VEI93A8FENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82FENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NFENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6FENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEFENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]1
TRIACETININACTIVE INGREDIENTXHX3C3X673FENOFIBRATE (FENOFIBRATE) TABLET [AVPAK]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 1 of 110 · 2,188 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
FenofibrateFENOFIBRATEA-S Medication Solutionsc870ea48-5dde-4a6f-9ddb-56b494bb2b552026-09-09Warnings, Adverse reactionsExact identifier
unii: U202363UOS
FENOFIBRATEFENOFIBRATEREMEDYREPACK INC.882ee82a-3c56-4173-af42-68c3aadc8aa72026-09-04Warnings, Adverse reactionsExact identifier
application number: ANDA076509
rxcui: 349287
unii: U202363UOS
FenofibrateFENOFIBRATEA-S Medication Solutionsd0c7070e-b3bb-4b5b-8a62-4e3136b5accc2026-08-28Warnings, Adverse reactionsExact identifier
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
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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