FENTANYL TRANSDERMAL SYSTEM

Product NDC
63629-5492
11-digit product format
636295492
Labeler code
63629
Product ID
63629-5492_5fd288e9-8f19-474c-a00f-3a86d2ce5358
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fentanyl transdermal system
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Bryant Ranch Prepack
Application
ANDA077154
Marketing category
ANDA
Marketing start
2011-06-06
Marketing end
0000-00-00
Substance
FENTANYL
Active strength
50 ug/h
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-5492-12023-03-08C16284748780-19d75b9d0-9658-f424-e053-dadaa90a57ce9393d796-fb80-4d65-8624-04aa1b82080d
63629-5492-12020-01-31C16284748780-19d75b9d0-9658-f424-e053-dadaa90a57ce9393d796-fb80-4d65-8624-04aa1b82080d

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-5492-1EA - Each63629-5492cab6cf30-6260-4db7-9f3b-1edade6571fd12017-07-07