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 9 of 117 · 2,325 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LUMINOUS EYE CORRECTOR SPF 41 - MEDIUMTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC0206c676-c24d-470e-adb2-7cb3173f37272026-05-04WarningsExact identifier
unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - TANTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC5c5aad09-9f93-4634-8db1-c67570b38b2b2026-05-04WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Sport SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories4955fa1c-789d-4f42-af75-70223310644a2026-05-01WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Kids SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratoriesba4ae906-48c0-8384-e053-2995a90afb912026-05-01WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2CR Cool RosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6831832a-e52e-43ea-899f-f5d44bea5a942026-04-30WarningsExact identifier
unii: 15FIX9V2JP
Tru Skin Rituals SPF 25TITANIUM DIOXIDE, ZINC OXIDESpa de Soleilf725cd5c-999e-2393-e053-6394a90a09dc2026-04-30WarningsExact identifier
unii: 15FIX9V2JP
FenofibrateFENOFIBRATEBostal LLCa5bc232c-ff27-f8b6-e053-2995a90ad3992026-04-29Warnings, Adverse reactionsExact identifier
unii: U202363UOS
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509cad98-0321-2a0a-e063-6294a90a6ea92026-04-29WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509d7206-0cc1-c997-e063-6294a90a89e02026-04-29WarningsExact identifier
unii: 15FIX9V2JP
JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREENHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEGPNY CORP211dea04-faad-8ffc-e063-6294a90a8d682026-04-29WarningsExact identifier
unii: 15FIX9V2JP
Anything SPFOCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDEAnything SPF LLC508b8dcb-6600-6dad-e063-6294a90a565a2026-04-28WarningsExact identifier
unii: 15FIX9V2JP
Johnsons Baby Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC4fe04c4b-2751-0561-e063-6394a90af7682026-04-22WarningsExact identifier
unii: 15FIX9V2JP
Lazy Face SPF 30 FacescreenTITANIUM DIOXIDE, ZINC OXIDESunny Day Creations500ee303-7302-68d5-e063-6394a90ac6d42026-04-22WarningsExact identifier
unii: 15FIX9V2JP
ELROEL Pang Pang Sun Cushion S7ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEMONOGLOT HOLDINGS Inc.256bf56f-aefa-47ce-890c-5a3896c11b922026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion FairTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.3a43c7c0-7468-4b7a-95b9-f03e37f1b49b2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.a251eb20-02e6-4b55-b969-c1bef2f9d7322026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair PinkTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.6684d69a-89ff-41e8-81f0-3e2367811a182026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.bf24d081-85f7-4a26-9416-ecff1fe59dec2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Pink LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.4a09a01a-404f-4b67-91e0-666153f550e82026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion N-LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.cf7c4445-0382-47ab-aba9-b40d63e4f1cc2026-04-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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