Fenofibrate

Product NDC
0115-1522
11-digit product format
001151522
Labeler code
0115
Product ID
0115-1522_da91e90a-03ad-4068-b158-fc5c5912e8bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
NDA022118
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-06-24
Marketing end
0000-00-00
Substance
FENOFIBRATE
Active strength
40 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0115-1522-102024-11-18C16284748780-1f386c649-e402-0266-e053-dadaa90a7c1a0c3a6ac7-aefa-4b10-88aa-01b702a4fe89
0115-1522-102023-01-30C16284748780-1f386c649-e402-0266-e053-dadaa90a7c1a0c3a6ac7-aefa-4b10-88aa-01b702a4fe89

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1522-10EA - Each0115-152288ee9181-da1e-4e98-9265-82e43f4b429412015-10-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1522FENOFIBRATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]14Legacy NDC20241120_0c3a6ac7-aefa-4b10-88aa-01b702a4fe89.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-1522-100011515221090 TABLET in 1 BOTTLE (0115-1522-10) 90 tablet2015-06-240000-00-00NoNoCurrent