FIBRICOR

Product NDC
70347-105
11-digit product format
703470105
Labeler code
70347
Product ID
70347-105_3f1da578-fd1e-4f75-b179-98bd4aef4178
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibric Acid
Dosage form
TABLET
Route
ORAL
Labeler
Aralez Pharmaceuticals US Inc.
Application
NDA022418
Marketing category
NDA
Marketing start
2017-08-05
Marketing end
0000-00-00
Substance
FENOFIBRIC ACID
Active strength
105 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70347-105-07FIBRICOR7 in 1 BOTTLE, PLASTICTABLET73
70347-105-30FIBRICOR30 in 1 BOTTLE, PLASTICTABLET303
70347-105-90FIBRICOR90 in 1 BOTTLE, PLASTICTABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70347-105-30EA - Each70347-105ab776e1e-3416-4362-b5b7-e224f8ac831812017-09-11
70347-105-90EA - Each70347-105482e20a3-2c34-4156-a20f-3c7151e7bfdf12017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70347-105FIBRICOR (FENOFIBRIC ACID) TABLET [ARALEZ PHARMACEUTICALS US INC.]3Legacy NDC, 3 package rows20181012_31c80f84-0169-4659-b9cf-8f897ed319eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860880fenofibric acid 105 MG Oral TabletPSN31c80f84-0169-4659-b9cf-8f897ed319eb3
860886fenofibric acid 35 MG Oral TabletPSN31c80f84-0169-4659-b9cf-8f897ed319eb3
860884FIBRICOR 105 MG Oral TabletPSN31c80f84-0169-4659-b9cf-8f897ed319eb3
860888FIBRICOR 35 MG Oral TabletPSN31c80f84-0169-4659-b9cf-8f897ed319eb3
860884fenofibric acid 105 MG Oral Tablet [Fibricor]SBD31c80f84-0169-4659-b9cf-8f897ed319eb3
860888fenofibric acid 35 MG Oral Tablet [Fibricor]SBD31c80f84-0169-4659-b9cf-8f897ed319eb3
860880fenofibric acid 105 MG Oral TabletSCD31c80f84-0169-4659-b9cf-8f897ed319eb3
860886fenofibric acid 35 MG Oral TabletSCD31c80f84-0169-4659-b9cf-8f897ed319eb3
860884Fibricor (fenofibric acid 105 MG) Oral TabletSY31c80f84-0169-4659-b9cf-8f897ed319eb3
860888Fibricor (fenofibric acid 35 MG) Oral TabletSY31c80f84-0169-4659-b9cf-8f897ed319eb3
860884Fibricor 105 MG Oral TabletSY31c80f84-0169-4659-b9cf-8f897ed319eb3
860888Fibricor 35 MG Oral TabletSY31c80f84-0169-4659-b9cf-8f897ed319eb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
70347-105-07703470105077 in 1 BOTTLE, PLASTICHistorical
70347-105-307034701053030 in 1 BOTTLE, PLASTICHistorical
70347-105-907034701059090 in 1 BOTTLE, PLASTICHistorical