FDA.reportPublic FDA data

FENOFIBRATE

Product NDC
70934-223
11-digit product format
709340223
Labeler code
70934
Product ID
70934-223_c1ad6073-63f4-669f-e053-2995a90aacee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENOFIBRATE
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA076509
Marketing category
ANDA
Marketing start
2019-01-09
Marketing end
0000-00-00
Substance
FENOFIBRATE
Active strength
160 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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
70934-223-302023-01-30C16284748780-1ba0f9c33-3114-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE Tablets, for oral use Initial U.S. Approval: 1993
70934-223-602023-01-30C16284748780-1ba0f9c33-3114-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE Tablets, for oral use Initial U.S. Approval: 1993
70934-223-302021-01-31C16284748780-1ba0f9c33-3114-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE Tablets, for oral use Initial U.S. Approval: 1993
70934-223-302021-01-29C16284748780-1ba0f9c33-3114-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE Tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-223-30FENOFIBRATE30 in 1 BOTTLE, PLASTICTABLET303
70934-223-60FENOFIBRATE60 in 1 BOTTLE, PLASTICTABLET603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-223-30EA - Each70934-2232560af3a-797f-471d-b815-1e9966f227a212022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-223FENOFIBRATE TABLET [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]3Legacy NDC, 2 package rows20210512_8771de7e-b066-ea00-e053-2a95a90a7512.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349287fenofibrate 160 MG Oral TabletPSN8771de7e-b066-ea00-e053-2a95a90a75123
349287fenofibrate 160 MG Oral TabletSCD8771de7e-b066-ea00-e053-2a95a90a75123

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-223-307093402233030 TABLET in 1 BOTTLE, PLASTIC (70934-223-30) 30 tablet2019-01-090000-00-00NoNoCurrent
70934-223-607093402236060 TABLET in 1 BOTTLE, PLASTIC (70934-223-60) 60 tablet2021-05-060000-00-00NoNoCurrent