Fenofibrate

Product NDC
68071-2812
11-digit product format
680712812
Labeler code
68071
Product ID
68071-2812_e64e1b44-75c5-a839-e053-2995a90a459c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA209504
Marketing category
ANDA
Marketing start
2018-05-01
Marketing end
0000-00-00
Substance
FENOFIBRATE
Active strength
134 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2812-32025-01-30C16284748780-12cef2736-6b5b-d83d-e063-dadaa90ab31fFenofibrate Capsules USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2812-3Fenofibrate30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2812FENOFIBRATE CAPSULE [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20220817_e64e125f-2b59-cb97-e053-2995a90a63f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310288fenofibrate 134 MG Oral CapsulePSNe64e125f-2b59-cb97-e053-2995a90a63f61
310288fenofibrate 134 MG Oral CapsuleSCDe64e125f-2b59-cb97-e053-2995a90a63f61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2812-36807128120330 CAPSULE in 1 BOTTLE (68071-2812-3) 30 capsule2022-08-150000-00-00NoNoCurrent