IONSYS

Product NDC
65293-011
11-digit product format
652930011
Labeler code
65293
Product ID
65293-011_45eac440-fb43-3509-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fentanyl iontophoretic transdermal system
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
The Medicines Company
Application
NDA021338
Marketing category
NDA
Marketing start
2015-06-01
Marketing end
0000-00-00
Substance
FENTANYL HYDROCHLORIDE
Active strength
40 ug/1
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
65293-011-062020-02-11C16284748780-19d75b9cf-ecf3-f424-e053-dadaa90a57cee95afc93-130c-4715-a4f8-ed2de904e2d2
65293-011-062020-01-31C16284748780-19d75b9cf-ecf3-f424-e053-dadaa90a57cee95afc93-130c-4715-a4f8-ed2de904e2d2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65293-011-01EA - Each65293-011628fc235-06c2-4678-99ec-ac5e7338a72712015-06-09
65293-011-06EA - Each65293-01110c5f707-33f8-42f9-9644-133d431193d612015-06-09