FDA.reportPublic FDA data

Fenoglide

Product NDC
52725-495
11-digit product format
527250495
Labeler code
52725
Product ID
52725-495_986c60c0-7d75-11e0-b654-0002a5d5c51b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
Shore Therapeutics, Inc
Application
NDA022118
Marketing category
NDA
Marketing start
2010-11-18
Marketing end
0000-00-00
Substance
FENOFIBRATE
Active strength
120 mg/1
Pharmacologic classes
Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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
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
52725-495-072020-01-31C16284748780-19d75b9d1-0a86-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Fenoglide ® safely and effectively. See full prescribing information for Fenoglide. Fenoglide (fenofibrate) Tablets Initial U.S. Approval: 1993
52725-495-902020-01-31C16284748780-19d75b9d1-0a86-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Fenoglide ® safely and effectively. See full prescribing information for Fenoglide. Fenoglide (fenofibrate) Tablets Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52725-495-07Fenoglide6 in 1 BOXTABLET62
52725-495-07Fenoglide7 in 1 BOTTLE, PLASTICTABLET72
52725-495-90Fenoglide90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
fenofibrateACTIVE INGREDIENTU202363UOSFENOGLIDE (FENOFIBRATE) TABLET [SHORE THERAPEUTICS, INC]2
fenofibrateACTIVE MOIETYU202363UOSFENOGLIDE (FENOFIBRATE) TABLET [SHORE THERAPEUTICS, INC]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XFENOGLIDE (FENOFIBRATE) TABLET [SHORE THERAPEUTICS, INC]2
magnesium stearateINACTIVE INGREDIENT70097M6I30FENOGLIDE (FENOFIBRATE) TABLET [SHORE THERAPEUTICS, INC]2
Poloxamer 188INACTIVE INGREDIENTLQA7B6G8JGFENOGLIDE (FENOFIBRATE) TABLET [SHORE THERAPEUTICS, INC]2
Polyethylene Glycol 6000INACTIVE INGREDIENT30IQX730WEFENOGLIDE (FENOFIBRATE) TABLET [SHORE THERAPEUTICS, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52725-495FENOGLIDE (FENOFIBRATE) TABLET [SHORE THERAPEUTICS, INC]2Legacy NDC, 3 package rows20110517_b38489c0-ee7b-11df-b958-0002a5d5c51b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749802fenofibrate 120 MG Oral TabletPSNb38489c0-ee7b-11df-b958-0002a5d5c51b2
749804fenofibrate 40 MG Oral TabletPSNb38489c0-ee7b-11df-b958-0002a5d5c51b2
763250Fenoglide 120 MG Oral TabletPSNb38489c0-ee7b-11df-b958-0002a5d5c51b2
763252Fenoglide 40 MG Oral TabletPSNb38489c0-ee7b-11df-b958-0002a5d5c51b2
763250fenofibrate 120 MG Oral Tablet [Fenoglide]SBDb38489c0-ee7b-11df-b958-0002a5d5c51b2
763252fenofibrate 40 MG Oral Tablet [Fenoglide]SBDb38489c0-ee7b-11df-b958-0002a5d5c51b2
749802fenofibrate 120 MG Oral TabletSCDb38489c0-ee7b-11df-b958-0002a5d5c51b2
749804fenofibrate 40 MG Oral TabletSCDb38489c0-ee7b-11df-b958-0002a5d5c51b2
763250Fenoglide 120 MG Oral TabletSYb38489c0-ee7b-11df-b958-0002a5d5c51b2
763252Fenoglide 40 MG Oral TabletSYb38489c0-ee7b-11df-b958-0002a5d5c51b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52725-495-07527250495076 in 1 BOXHistorical
52725-495-905272504959090 in 1 BOTTLE, PLASTICHistorical