FENOFIBRATE

Product NDC
60760-318
11-digit product format
607600318
Labeler code
60760
Product ID
60760-318_f19d9517-2849-516f-e053-2995a90ad6e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENOFIBRATE
Dosage form
TABLET
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA213864
Marketing category
ANDA
Marketing start
2021-01-14
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

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
60760-318-30FENOFIBRATE30 in 1 BOTTLE, PLASTICTABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-318-30EA - Each60760-318140a1c89-9f61-4420-81f9-a05d9e41d48712021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-318FENOFIBRATE TABLET [ST. MARY'S MEDICAL PARK PHARMACY]2Current NDC, Legacy NDC, 1 package rows20230107_b92fb19a-d0df-426e-e053-2995a90ab379.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349287fenofibrate 160 MG Oral TabletPSNb92fb19a-d0df-426e-e053-2995a90ab3792
349287fenofibrate 160 MG Oral TabletSCDb92fb19a-d0df-426e-e053-2995a90ab3792

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-318-306076003183030 TABLET in 1 BOTTLE, PLASTIC (60760-318-30) 30 tablet2021-01-140000-00-00NoNoCurrent