Fenofibric Acid

Product NDC
68382-233
11-digit product format
683820233
Labeler code
68382
Product ID
68382-233_7510c070-1b49-41a2-a3ea-cbbbde665013
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibric Acid
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc
Application
NDA022224
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-09-12
Marketing end
0000-00-00
Substance
FENOFIBRIC ACID
Active strength
135 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68382-233-162020-02-29C16284748780-19d75b9d0-c436-f424-e053-dadaa90a57ceec89235b-930a-bd1d-cb02-7f702cc38d7a
68382-233-162020-01-31C16284748780-19d75b9d0-c436-f424-e053-dadaa90a57ceec89235b-930a-bd1d-cb02-7f702cc38d7a

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-233-16EA - Each68382-2331ea711b6-bc86-4dd8-a60d-cdd72010b1ea12017-03-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-233-166838202331690 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-233-16) 2016-09-120000-00-00NoNoCurrent