FDA.reportPublic FDA data

Fenofibrate

Product NDC
63304-449
11-digit product format
633040449
Labeler code
63304
Product ID
63304-449_2cd2c807-d4f7-51da-e063-6294a90a9a63
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fenofibrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA200884
Marketing category
ANDA
Marketing start
2018-06-01
Substance
FENOFIBRATE
Active strength
145 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
FENOFIBRATE145 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU202363UOS
Rxcui477560, 477562

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
63304-449-05Fenofibrate500 in 1 BOTTLETABLET, FILM COATED50012
63304-449-30Fenofibrate30 in 1 BOTTLETABLET, FILM COATED3012
63304-449-90Fenofibrate90 in 1 BOTTLETABLET, FILM COATED9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-449-05EA - Each63304-4499b15eb41-76b4-4755-99ba-0002155dc1f112018-06-11
63304-449-90EA - Each63304-4493488c623-edff-4ab7-9c86-eaacd6c541e312018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-449FENOFIBRATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]12Current NDC, Legacy NDC, 3 package rows20250130_125bbd7e-86a2-4209-90a5-ad353e572d1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477560fenofibrate 145 MG Oral TabletPSN125bbd7e-86a2-4209-90a5-ad353e572d1b12
477562fenofibrate 48 MG Oral TabletPSN125bbd7e-86a2-4209-90a5-ad353e572d1b12
477560fenofibrate 145 MG Oral TabletSCD125bbd7e-86a2-4209-90a5-ad353e572d1b12
477562fenofibrate 48 MG Oral TabletSCD125bbd7e-86a2-4209-90a5-ad353e572d1b12
477560fenofibrate 145 MG Oral TabletPSN3db58c5c-b862-4871-b3f9-597aaeba56c45
477560fenofibrate 145 MG Oral TabletSCD3db58c5c-b862-4871-b3f9-597aaeba56c45
477560fenofibrate 145 MG Oral TabletPSN06870192-c92a-40c7-a619-efda0c0063014
477560fenofibrate 145 MG Oral TabletSCD06870192-c92a-40c7-a619-efda0c0063014
477560fenofibrate 145 MG Oral TabletPSN8772816e-4c85-0d07-e053-2a95a90a9c192
477560fenofibrate 145 MG Oral TabletPSNf2f46239-951d-fc0e-e053-2995a90ae9792
477560fenofibrate 145 MG Oral TabletSCD8772816e-4c85-0d07-e053-2a95a90a9c192
477560fenofibrate 145 MG Oral TabletSCDf2f46239-951d-fc0e-e053-2995a90ae9792

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63304-449-0563304044905500 TABLET, FILM COATED in 1 BOTTLE (63304-449-05) 2018-06-010000-00-00NoNoCurrent
63304-449-306330404493030 TABLET, FILM COATED in 1 BOTTLE (63304-449-30) 2018-06-010000-00-00NoNoCurrent
63304-449-906330404499090 TABLET, FILM COATED in 1 BOTTLE (63304-449-90) 2018-06-010000-00-00NoNoCurrent