Fentanyl

Product NDC
0591-3214
11-digit product format
005913214
Labeler code
0591
Product ID
0591-3214_89a9c234-ef0a-4c40-8473-3ccd17c9640b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fentanyl
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Actavis Pharma, Inc.
Application
ANDA076709
Marketing category
ANDA
Marketing start
2007-08-21
Marketing end
2019-06-30
Substance
FENTANYL
Active strength
100 ug/h
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3214-54EA - Each0591-3214781b8f51-5af2-476b-958f-06349659e4d912012-07-24
0591-3214-72EA - Each0591-3214e4a37e9e-ddf9-4cf3-a6b6-25b6a03239d212012-07-24