fenofibrate

Product NDC
71205-190
11-digit product format
712050190
Labeler code
71205
Product ID
71205-190_27025f51-5dff-4994-aab0-310895239337
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA210138
Marketing category
ANDA
Marketing start
2018-07-20
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
71205-190-30fenofibrate30 in 1 BOTTLETABLET303
71205-190-60fenofibrate60 in 1 BOTTLETABLET603
71205-190-90fenofibrate90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-190-30EA - Each71205-19004194e65-53f8-4417-97c6-37f186222d5d12023-08-08
71205-190-90EA - Each71205-19026351f2a-1eab-409e-817e-a7364799d37412019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-190FENOFIBRATE TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20221111_b9a6866c-9dbe-4419-bcad-52ec0127821f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349287fenofibrate 160 MG Oral TabletPSNb9a6866c-9dbe-4419-bcad-52ec0127821f3
349287fenofibrate 160 MG Oral TabletSCDb9a6866c-9dbe-4419-bcad-52ec0127821f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-190-307120501903030 TABLET in 1 BOTTLE (71205-190-30) 30 tablet2019-01-010000-00-00NoNoCurrent
71205-190-607120501906060 TABLET in 1 BOTTLE (71205-190-60) 60 tablet2019-01-010000-00-00NoNoCurrent
71205-190-907120501909090 TABLET in 1 BOTTLE (71205-190-90) 90 tablet2019-01-010000-00-00NoNoCurrent