FDA.reportPublic FDA data

NDC 68084-835-33 - 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
68084-835
Requested NDC
68084-835-33
Package NDCs from labels
68084-835-33, 68084-835-32
Manufacturer
American Health Packaging
Effective date
2022-08-10
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 Packaging2022-08-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-835-32EA - Each68084-83544a95652-301e-40c6-ae4d-a10d29db64c612014-12-01
68084-835-33EA - Each68084-83598dd733c-40d0-4b21-9c7f-44edc72e2bfb12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENOFIBRATEACTIVE INGREDIENTU202363UOSFENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING]4
FENOFIBRATEACTIVE MOIETYU202363UOSFENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933FENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING]4
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHFENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING]4
GELATININACTIVE INGREDIENT2G86QN327LFENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING]4
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6FENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING]4
SHELLACINACTIVE INGREDIENT46N107B71OFENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING]4

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 3 of 117 · 2,325 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
unii: 6DC9Q167V3
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
unii: 6DC9Q167V3
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
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP
FenofibrateFENOFIBRATEBostal LLC7eb328d0-4e6f-4b24-ae85-68c2b36575692026-06-30Warnings, Adverse reactionsExact identifier
unii: U202363UOS
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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