FENOFIBRATE

Product NDC
70756-214
11-digit product format
707560214
Labeler code
70756
Product ID
70756-214_4a13e20b-6a21-4d45-a159-a2add4ce215e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENOFIBRATE
Dosage form
TABLET
Route
ORAL
Labeler
Lifestar Pharma LLC
Application
ANDA213864
Marketing category
ANDA
Marketing start
2020-09-10
Substance
FENOFIBRATE
Active strength
54 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
FENOFIBRATE54 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU202363UOS
Rxcui349287, 351133

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
70756-214-51FENOFIBRATE500 in 1 BOTTLETABLET5008
70756-214-90FENOFIBRATE90 in 1 BOTTLETABLET908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-214FENOFIBRATE TABLET [LIFESTAR PHARMA LLC]7Current NDC, Legacy NDC, 2 package rows20221227_1da57e8c-3977-43e1-aa7e-229760203f7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349287fenofibrate 160 MG Oral TabletPSN1da57e8c-3977-43e1-aa7e-229760203f7d8
351133fenofibrate 54 MG Oral TabletPSN1da57e8c-3977-43e1-aa7e-229760203f7d8
351133fenofibrate 54 MG Oral TabletPSNb79efcf4-6016-4a1f-b83f-be00baa25c218
349287fenofibrate 160 MG Oral TabletSCD1da57e8c-3977-43e1-aa7e-229760203f7d8
351133fenofibrate 54 MG Oral TabletSCD1da57e8c-3977-43e1-aa7e-229760203f7d8
351133fenofibrate 54 MG Oral TabletSCDb79efcf4-6016-4a1f-b83f-be00baa25c218
351133fenofibrate 54 MG Oral TabletPSN26f8f793-fb7a-4327-9441-d8737fe1ff111
351133fenofibrate 54 MG Oral TabletSCD26f8f793-fb7a-4327-9441-d8737fe1ff111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70756-214-5170756021451500 TABLET in 1 BOTTLE (70756-214-51) 500 tablet2020-09-100000-00-00NoNoCurrent
70756-214-907075602149090 TABLET in 1 BOTTLE (70756-214-90) 90 tablet2020-09-100000-00-00NoNoCurrent