Fenofibrate

Product NDC
60687-713
11-digit product format
606870713
Labeler code
60687
Product ID
60687-713_2e998ded-7131-60ae-e063-6294a90a9e67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA205566
Marketing category
ANDA
Marketing start
2023-03-13
Substance
FENOFIBRATE
Active strength
200 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
FENOFIBRATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU202363UOS
Rxcui310289

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
60687-713-11Fenofibrate1 in 1 BLISTER PACKCAPSULE14
60687-713-21Fenofibrate30 in 1 CARTONCAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-713-11EA - Each60687-713cfb82628-dd33-4e4e-ac2f-bb894cccc0f612023-03-13
60687-713-21EA - Each60687-713a5193397-686b-498f-a079-8010c943512512023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-713FENOFIBRATE CAPSULE [AMERICAN HEALTH PACKAGING]4Current NDC, Legacy NDC, 2 package rows20250223_8b4488f4-bef6-408c-9fca-3e4aebceff9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310289fenofibrate 200 MG Oral CapsulePSN8b4488f4-bef6-408c-9fca-3e4aebceff9a4
310289fenofibrate 200 MG Oral CapsuleSCD8b4488f4-bef6-408c-9fca-3e4aebceff9a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-713-11606870713111 in 1 BLISTER PACKHistorical
60687-713-216068707132130 BLISTER PACK in 1 CARTON (60687-713-21) / 1 CAPSULE in 1 BLISTER PACK (60687-713-11) 30 blister pack2023-03-130000-00-00NoNoCurrent