FDA.reportPublic FDA data

NDC 68084-827-95 - 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
68084-827
Requested NDC
68084-827-95
Package NDCs from labels
68084-827-95, 68084-827-25
Manufacturer
American Health Packaging
Effective date
2023-01-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fenofibrate - American Health PackagingAmerican Health Packaging2023-01-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-827-11EA - Each68084-82790036168-fc76-4322-a91b-dadd6c659d5a12014-12-01
68084-827-21EA - Each68084-8270ada0ca1-8267-4de7-829a-b87c9265de0c12014-12-01
68084-827-25EA - Each68084-827d32e2613-e736-4030-82bf-263672861c8a12016-02-04
68084-827-95EA - Each68084-827d8bc7476-bc90-4bf0-9846-09534421acbf12016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENOFIBRATEACTIVE INGREDIENTU202363UOSFENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]6
FENOFIBRATEACTIVE MOIETYU202363UOSFENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]6
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]6
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NFENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]6
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]6
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEFENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]6
TRIACETININACTIVE INGREDIENTXHX3C3X673FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]6

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 2 of 108 · 2,146 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
FENOFIBRATEFENOFIBRATEREMEDYREPACK INC.3b6c5ebd-a8bc-4502-8b66-f4e58914815b2026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 349287
unii: U202363UOS
FenofibrateFENOFIBRATEGolden State Medical Supply, Inc.3e611f91-e351-9558-e063-6394a90ace172026-07-27Warnings, Adverse reactionsExact identifier
unii: U202363UOS
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
FenofibrateFENOFIBRATEMajor Pharmaceuticalsd9be3ae3-6da9-47fd-bcfd-e561b9d585ca2026-07-16Warnings, Adverse reactionsExact identifier
unii: U202363UOS
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
FenofibrateFENOFIBRATEAmerican Health Packaging8b4488f4-bef6-408c-9fca-3e4aebceff9a2026-07-02Warnings, Adverse reactionsExact identifier
unii: U202363UOS
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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