fenofibrate

Product NDC
45802-315
11-digit product format
458020315
Labeler code
45802
Product ID
45802-315_3d36df54-b4b4-43aa-b1e2-e33badea03bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA090715
Marketing category
ANDA
Marketing start
2014-08-13
Marketing end
0000-00-00
Substance
FENOFIBRATE
Active strength
48 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-315-75EA - Each45802-3151a3f4f08-67f5-4feb-a924-ad7270e063ec12014-09-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-315-754580203157590 TABLET in 1 BOTTLE (45802-315-75) 90 tablet2014-09-230000-00-00NoNoCurrent