FDA.reportPublic FDA data

Fenofibrate

Product NDC
33342-340
11-digit product format
333420340
Labeler code
33342
Product ID
33342-340_ab7aad70-2879-4260-831e-cbfbe8be73b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA210248
Marketing category
ANDA
Marketing start
2024-11-13
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
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
33342-340-07Fenofibrate30 in 1 BOTTLETABLET302
33342-340-10Fenofibrate90 in 1 BOTTLETABLET902
33342-340-12Fenofibrate10 in 1 BLISTER PACKTABLET102
33342-340-12Fenofibrate10 in 1 CARTONTABLET102
33342-340-15Fenofibrate500 in 1 BOTTLETABLET5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-340FENOFIBRATE TABLET [MACLEODS PHARMACEUTICALS LIMITED]1Current NDC, 5 package rows20250210_e8b9d1f5-0541-424f-b1d4-bef6381aa934.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477560fenofibrate 145 MG Oral TabletPSNe8b9d1f5-0541-424f-b1d4-bef6381aa9342
477562fenofibrate 48 MG Oral TabletPSNe8b9d1f5-0541-424f-b1d4-bef6381aa9342
477560fenofibrate 145 MG Oral TabletSCDe8b9d1f5-0541-424f-b1d4-bef6381aa9342
477562fenofibrate 48 MG Oral TabletSCDe8b9d1f5-0541-424f-b1d4-bef6381aa9342

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-340-073334203400730 TABLET in 1 BOTTLE (33342-340-07) 30 tablet2024-11-13NoNoCurrent
33342-340-103334203401090 TABLET in 1 BOTTLE (33342-340-10) 90 tablet2024-11-13NoNoCurrent
33342-340-123334203401210 BLISTER PACK in 1 CARTON (33342-340-12) / 10 TABLET in 1 BLISTER PACK10 blister pack2024-11-13NoNoCurrent
33342-340-1533342034015500 TABLET in 1 BOTTLE (33342-340-15) 500 tablet2024-11-13NoNoCurrent