FDA.reportPublic FDA data

FENOFIBRATE

Product NDC
60219-5522
11-digit product format
602195522
Labeler code
60219
Product ID
60219-5522_cd7dc10f-f401-4e24-8be8-86aa08151ddc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENOFIBRATE
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA076509
Marketing category
ANDA
Marketing start
2022-06-22
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
60219-5522-5FENOFIBRATE500 in 1 BOTTLETABLET5004
60219-5522-9FENOFIBRATE90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-5522-5EA - Each60219-5522114f03e2-3c11-48d2-ad0d-6f8a6370aa4a12022-12-07
60219-5522-9EA - Each60219-5522d0afb12b-bda0-4c36-85fb-560b529607cc12022-10-06

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
60219-5522FENOFIBRATE TABLET [AMNEAL PHARMACEUTICALS NY LLC]4Current NDC, Legacy NDC, 2 package rows20241210_65f5dcad-5073-4347-9ec9-e7f350b134c4.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
349287fenofibrate 160 MG Oral TabletPSN35ba17d9-0dd7-4f15-8f74-be5fd15f19175
349287fenofibrate 160 MG Oral TabletSCD35ba17d9-0dd7-4f15-8f74-be5fd15f19175
349287fenofibrate 160 MG Oral TabletPSN65f5dcad-5073-4347-9ec9-e7f350b134c44
351133fenofibrate 54 MG Oral TabletPSN65f5dcad-5073-4347-9ec9-e7f350b134c44
349287fenofibrate 160 MG Oral TabletSCD65f5dcad-5073-4347-9ec9-e7f350b134c44
351133fenofibrate 54 MG Oral TabletSCD65f5dcad-5073-4347-9ec9-e7f350b134c44
349287fenofibrate 160 MG Oral TabletPSN3f2b3a16-7735-487e-9a2c-e078a18df1bc3
349287fenofibrate 160 MG Oral TabletSCD3f2b3a16-7735-487e-9a2c-e078a18df1bc3
349287fenofibrate 160 MG Oral TabletPSN882ee82a-3c56-4173-af42-68c3aadc8aa72
349287fenofibrate 160 MG Oral TabletSCD882ee82a-3c56-4173-af42-68c3aadc8aa72
349287fenofibrate 160 MG Oral TabletPSNf937a176-3d3e-4dc6-a7d4-c1a4749c7a7f1
349287fenofibrate 160 MG Oral TabletSCDf937a176-3d3e-4dc6-a7d4-c1a4749c7a7f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60219-5522-560219552205500 TABLET in 1 BOTTLE (60219-5522-5) 500 tablet2022-06-220000-00-00NoNoCurrent
60219-5522-96021955220990 TABLET in 1 BOTTLE (60219-5522-9) 90 tablet2022-06-220000-00-00NoNoCurrent