fenofibrate

Product NDC
68788-7578
11-digit product format
687887578
Labeler code
68788
Product ID
68788-7578_162d1fe6-ab5a-47de-a6a3-cf621b05b0fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA210138
Marketing category
ANDA
Marketing start
2018-07-20
Marketing end
0000-00-00
Substance
FENOFIBRATE
Active strength
160 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7578-1EA - Each68788-75782bf3eac7-3345-4372-9251-af98c53ed87612020-09-14
68788-7578-3EA - Each68788-7578759b4ad2-7b8c-408e-bc81-4deea177507d12020-09-14
68788-7578-6EA - Each68788-7578946c39cb-42d6-4a21-adcc-120282b128d012020-09-14
68788-7578-9EA - Each68788-7578606f9009-0666-4a59-b5ae-e103959e1cfc12020-09-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7578-168788757801100 TABLET in 1 BOTTLE (68788-7578-1) 100 tablet2019-12-270000-00-00NoNoCurrent
68788-7578-36878875780330 TABLET in 1 BOTTLE (68788-7578-3) 30 tablet2019-12-270000-00-00NoNoCurrent
68788-7578-66878875780660 TABLET in 1 BOTTLE (68788-7578-6) 60 tablet2019-12-270000-00-00NoNoCurrent
68788-7578-96878875780990 TABLET in 1 BOTTLE (68788-7578-9) 90 tablet2019-12-270000-00-00NoNoCurrent