Fenofibrate

Product NDC
60687-629
11-digit product format
606870629
Labeler code
60687
Product ID
60687-629_401cf11f-0460-cfda-e063-6394a90ab3dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA090856
Marketing category
ANDA
Marketing start
2021-06-24
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
60687-629-01Fenofibrate100 in 1 CARTONTABLET1007
60687-629-11Fenofibrate1 in 1 BLISTER PACKTABLET17
60687-629-21Fenofibrate30 in 1 BOX, UNIT-DOSETABLET307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-629FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]6Current NDC, Legacy NDC, 3 package rows20241218_d1f64796-6ba0-415c-a6a0-5456b21a7ed6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477560fenofibrate 145 MG Oral TabletPSNd1f64796-6ba0-415c-a6a0-5456b21a7ed67
477562fenofibrate 48 MG Oral TabletPSNd1f64796-6ba0-415c-a6a0-5456b21a7ed67
477560fenofibrate 145 MG Oral TabletSCDd1f64796-6ba0-415c-a6a0-5456b21a7ed67
477562fenofibrate 48 MG Oral TabletSCDd1f64796-6ba0-415c-a6a0-5456b21a7ed67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-629-0160687062901100 BLISTER PACK in 1 CARTON (60687-629-01) / 1 TABLET in 1 BLISTER PACK (60687-629-11) 100 blister pack2023-03-08NoNoCurrent
60687-629-11606870629111 in 1 BLISTER PACKHistorical
60687-629-216068706292130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-629-21) / 1 TABLET in 1 BLISTER PACK (60687-629-11) 30 blister pack2021-06-240000-00-00NoNoCurrent