FDA.reportPublic FDA data

FIBRICOR

Product NDC
13310-101
11-digit product format
133100101
Labeler code
13310
Product ID
13310-101_26bcf80c-8314-4e10-b32c-452dbce94f7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibric Acid
Dosage form
TABLET
Route
ORAL
Labeler
AR Scientific, Inc.
Application
NDA022418
Marketing category
NDA
Marketing start
2009-08-14
Marketing end
0000-00-00
Substance
FENOFIBRIC ACID
Active strength
35 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13310-101-012019-11-27C16284748780-19855d018-e8cd-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use FIBRICOR ® (fenofibric acid) Tablets safely and effectively. See full prescribing information for FIBRICOR. FIBRICOR ® (fenofibric acid) Tablets, for oral use Initial U.S. Approval: 1993
13310-101-032019-11-27C16284748780-19855d018-e8cd-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use FIBRICOR ® (fenofibric acid) Tablets safely and effectively. See full prescribing information for FIBRICOR. FIBRICOR ® (fenofibric acid) Tablets, for oral use Initial U.S. Approval: 1993
13310-101-052019-11-27C16284748780-19855d018-e8cd-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use FIBRICOR ® (fenofibric acid) Tablets safely and effectively. See full prescribing information for FIBRICOR. FIBRICOR ® (fenofibric acid) Tablets, for oral use Initial U.S. Approval: 1993
13310-101-062019-11-27C16284748780-19855d018-e8cd-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use FIBRICOR ® (fenofibric acid) Tablets safely and effectively. See full prescribing information for FIBRICOR. FIBRICOR ® (fenofibric acid) Tablets, for oral use Initial U.S. Approval: 1993
13310-101-072019-11-27C16284748780-19855d018-e8cd-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use FIBRICOR ® (fenofibric acid) Tablets safely and effectively. See full prescribing information for FIBRICOR. FIBRICOR ® (fenofibric acid) Tablets, for oral use Initial U.S. Approval: 1993
13310-101-102019-11-27C16284748780-19855d018-e8cd-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use FIBRICOR ® (fenofibric acid) Tablets safely and effectively. See full prescribing information for FIBRICOR. FIBRICOR ® (fenofibric acid) Tablets, for oral use Initial U.S. Approval: 1993
13310-101-902019-11-27C16284748780-19855d018-e8cd-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use FIBRICOR ® (fenofibric acid) Tablets safely and effectively. See full prescribing information for FIBRICOR. FIBRICOR ® (fenofibric acid) Tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13310-101-01FIBRICOR100 in 1 BOTTLE, PLASTICTABLET10013
13310-101-03FIBRICOR250 in 1 BOTTLE, PLASTICTABLET25013
13310-101-05FIBRICOR500 in 1 BOTTLE, PLASTICTABLET50013
13310-101-06FIBRICOR60 in 1 BOTTLE, PLASTICTABLET6013
13310-101-07FIBRICOR30 in 1 BOTTLE, PLASTICTABLET3013
13310-101-10FIBRICOR1000 in 1 BOTTLE, PLASTICTABLET100013
13310-101-90FIBRICOR90 in 1 BOTTLE, PLASTICTABLET9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13310-101-07EA - Each13310-1018a0c41a0-b0ad-4b86-b9f9-8d76f1a6837812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Fenofibric AcidACTIVE INGREDIENTBGF9MN2HU1FIBRICOR (FENOFIBRIC ACID) TABLET [AR SCIENTIFIC, INC.]13
Fenofibric AcidACTIVE MOIETYBGF9MN2HU1FIBRICOR (FENOFIBRIC ACID) TABLET [AR SCIENTIFIC, INC.]13
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UFIBRICOR (FENOFIBRIC ACID) TABLET [AR SCIENTIFIC, INC.]13
copovidone K25-31INACTIVE INGREDIENTD9C330MD8BFIBRICOR (FENOFIBRIC ACID) TABLET [AR SCIENTIFIC, INC.]13
crospovidoneINACTIVE INGREDIENT68401960MKFIBRICOR (FENOFIBRIC ACID) TABLET [AR SCIENTIFIC, INC.]13
magnesium stearateINACTIVE INGREDIENT70097M6I30FIBRICOR (FENOFIBRIC ACID) TABLET [AR SCIENTIFIC, INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13310-101FIBRICOR (FENOFIBRIC ACID) TABLET [AR SCIENTIFIC, INC.]13Legacy NDC, 7 package rows20130321_86c49aff-0a4a-46b5-ac6e-26789bf17c9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860880fenofibric acid 105 MG Oral TabletPSN86c49aff-0a4a-46b5-ac6e-26789bf17c9b13
860886fenofibric acid 35 MG Oral TabletPSN86c49aff-0a4a-46b5-ac6e-26789bf17c9b13
860884FIBRICOR 105 MG Oral TabletPSN86c49aff-0a4a-46b5-ac6e-26789bf17c9b13
860888FIBRICOR 35 MG Oral TabletPSN86c49aff-0a4a-46b5-ac6e-26789bf17c9b13
860884fenofibric acid 105 MG Oral Tablet [Fibricor]SBD86c49aff-0a4a-46b5-ac6e-26789bf17c9b13
860888fenofibric acid 35 MG Oral Tablet [Fibricor]SBD86c49aff-0a4a-46b5-ac6e-26789bf17c9b13
860880fenofibric acid 105 MG Oral TabletSCD86c49aff-0a4a-46b5-ac6e-26789bf17c9b13
860886fenofibric acid 35 MG Oral TabletSCD86c49aff-0a4a-46b5-ac6e-26789bf17c9b13
860884Fibricor (fenofibric acid 105 MG) Oral TabletSY86c49aff-0a4a-46b5-ac6e-26789bf17c9b13
860888Fibricor (fenofibric acid 35 MG) Oral TabletSY86c49aff-0a4a-46b5-ac6e-26789bf17c9b13
860884Fibricor 105 MG Oral TabletSY86c49aff-0a4a-46b5-ac6e-26789bf17c9b13
860888Fibricor 35 MG Oral TabletSY86c49aff-0a4a-46b5-ac6e-26789bf17c9b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
13310-101-0113310010101100 in 1 BOTTLE, PLASTICHistorical
13310-101-0313310010103250 in 1 BOTTLE, PLASTICHistorical
13310-101-0513310010105500 in 1 BOTTLE, PLASTICHistorical
13310-101-061331001010660 in 1 BOTTLE, PLASTICHistorical
13310-101-071331001010730 in 1 BOTTLE, PLASTICHistorical
13310-101-10133100101101000 in 1 BOTTLE, PLASTICHistorical
13310-101-901331001019090 in 1 BOTTLE, PLASTICHistorical