FDA.reportPublic FDA data

Fenofibrate

Product NDC
35561-250
11-digit product format
355610250
Labeler code
35561
Product ID
35561-250_4dd565a9-088a-36f9-e063-6394a90ac5e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bostal LLC
Application
ANDA208476
Marketing category
ANDA
Marketing start
2021-01-01
Substance
FENOFIBRATE
Active strength
145 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fenofibrate
Listing expiration
2027-12-31

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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
cfc78bfa-7d55-47e5-aeb7-71cd79f5ca07Product name820231212
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
53d5b6b7-785a-4500-9460-263c7f8424b8Product name520210105
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
ed9d55d4-85bd-0ee7-5b4a-b705646a3a66Product name920200708
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
36a239c8-03fb-0083-81af-6c1afb195671Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
a0296d70-ca85-018c-84e8-cf3f630976b7Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
f2e3e9c8-a2f9-0cc3-a5a5-6dfd0279372aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35561-250-03Fenofibrate500 in 1 BOTTLETABLET, FILM COATED50011
35561-250-10Fenofibrate30 in 1 BOTTLETABLET, FILM COATED3011
35561-250-11Fenofibrate90 in 1 BOTTLETABLET, FILM COATED9011
35561-250-13Fenofibrate500 in 1 BOTTLETABLET, FILM COATED50011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35561-250FENOFIBRATE TABLET, FILM COATED [AUSTARPHARMA, LLC]7Current NDC, 4 package rows20240925_7eb328d0-4e6f-4b24-ae85-68c2b3657569.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477560fenofibrate 145 MG Oral TabletPSN7eb328d0-4e6f-4b24-ae85-68c2b365756911
477562fenofibrate 48 MG Oral TabletPSN7eb328d0-4e6f-4b24-ae85-68c2b365756911
477560fenofibrate 145 MG Oral TabletSCD7eb328d0-4e6f-4b24-ae85-68c2b365756911
477562fenofibrate 48 MG Oral TabletSCD7eb328d0-4e6f-4b24-ae85-68c2b365756911
477560fenofibrate 145 MG Oral TabletPSN3e611f91-e351-9558-e063-6394a90ace173
477562fenofibrate 48 MG Oral TabletPSN3e611f91-e351-9558-e063-6394a90ace173
477560fenofibrate 145 MG Oral TabletSCD3e611f91-e351-9558-e063-6394a90ace173
477562fenofibrate 48 MG Oral TabletSCD3e611f91-e351-9558-e063-6394a90ace173

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
35561-250-0335561025003500 TABLET, FILM COATED in 1 BOTTLE (35561-250-03) 2025-08-07NoNoCurrent
35561-250-103556102501030 TABLET, FILM COATED in 1 BOTTLE (35561-250-10) 2021-01-01NoNoCurrent
35561-250-113556102501190 TABLET, FILM COATED in 1 BOTTLE (35561-250-11) 2025-08-15NoNoCurrent
35561-250-1335561025013500 TABLET, FILM COATED in 1 BOTTLE (35561-250-13) 2021-01-01NoNoCurrent