FENTANYL TRANSDERMAL

Product NDC
0406-9012
11-digit product format
004069012
Labeler code
0406
Product ID
0406-9012_301a8c6d-a664-4eac-9c9e-8c47eb34dae4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fentanyl transdermal
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
SpecGx LLC
Application
ANDA077154
Marketing category
ANDA
Marketing start
2011-02-09
Marketing end
0000-00-00
Substance
FENTANYL
Active strength
13 ug/h
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-9012-76EA - Each0406-90120a44079a-0682-43f8-90bc-422514c6d31e12015-07-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0406-9012-76004069012765 POUCH in 1 CARTON (0406-9012-76) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH5 pouch2011-02-090000-00-00NoNoCurrent