FDA.reportPublic FDA data

FENOFIBRATE

Product NDC
50268-313
11-digit product format
502680313
Labeler code
50268
Product ID
50268-313_43bf4291-a298-f2fe-e063-6394a90a8fb3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENOFIBRATE
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA076509
Marketing category
ANDA
Marketing start
2015-08-13
Substance
FENOFIBRATE
Active strength
160 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FENOFIBRATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENOFIBRATE160 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU202363UOS
Rxcui349287, 351133

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
193bb7da-5c03-8f95-9048-23ef403846b0Product name320250616
fa35fb9a-7146-716b-13c8-bc1f60030232Product name920250114
cfc78bfa-7d55-47e5-aeb7-71cd79f5ca07Product name820231212
53d5b6b7-785a-4500-9460-263c7f8424b8Product name520210105
ed9d55d4-85bd-0ee7-5b4a-b705646a3a66Product name920200708
36a239c8-03fb-0083-81af-6c1afb195671Product name120140508
a0296d70-ca85-018c-84e8-cf3f630976b7Product name120140508
f2e3e9c8-a2f9-0cc3-a5a5-6dfd0279372aProduct name120140508

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349287fenofibrate 160 MG Oral TabletPSNd4e1d692-3c03-7406-ee06-7a6fb39ed3e76
351133fenofibrate 54 MG Oral TabletPSNd4e1d692-3c03-7406-ee06-7a6fb39ed3e76
349287fenofibrate 160 MG Oral TabletSCDd4e1d692-3c03-7406-ee06-7a6fb39ed3e76
351133fenofibrate 54 MG Oral TabletSCDd4e1d692-3c03-7406-ee06-7a6fb39ed3e76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-313-11502680313111 in 1 BLISTER PACKHistorical
50268-313-155026803131550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-313-15) / 1 TABLET in 1 BLISTER PACK (50268-313-11) 50 blister pack2015-08-130000-00-00NoNoCurrent